guaifenesin (58602-811) | FunFoxMeds NDC

Drug Facts

Product Profile

Brand Name guaifenesin

Generic Name guaifenesin

Labeler aurohealth llc

Dosage Form TABLET, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

guaifenesin 1200 mg/1

Manufacturer

Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-811

Product ID 58602-811_209f74eb-400d-40fe-943e-cecd8aec3a1d

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA210453

Listing Expiration 2026-12-31

Marketing Start 2019-10-21

Pharmacologic Class

Established (EPC)

expectorant [epc]

Physiologic Effect

decreased respiratory secretion viscosity [pe] increased respiratory secretions [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58602811

Hyphenated Format 58602-811

Supplemental Identifiers

RxCUI

310621

UNII

495W7451VQ

NUI

N0000193956 N0000008867 N0000009560

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name guaifenesin (source: ndc)

Generic Name guaifenesin (source: ndc)

Application Number ANDA210453 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

1200 mg/1

source: ndc

Packaging

1 BLISTER PACK in 1 CARTON (58602-811-01) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
2 BLISTER PACK in 1 CARTON (58602-811-02) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
3 BLISTER PACK in 1 CARTON (58602-811-03) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
1 BOTTLE in 1 CARTON (58602-811-05) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE
1 BOTTLE in 1 CARTON (58602-811-12) / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-811-21)
4 BLISTER PACK in 1 CARTON (58602-811-56) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
1 BOTTLE in 1 CARTON (58602-811-57) / 28 TABLET, EXTENDED RELEASE in 1 BOTTLE
1 BOTTLE in 1 CARTON (58602-811-60) / 42 TABLET, EXTENDED RELEASE in 1 BOTTLE
1 BLISTER PACK in 1 CARTON (58602-811-64) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
1 BOTTLE in 1 CARTON (58602-811-73) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE

source: ndc

Packages (11)

Ingredients (1)

guaifenesin (1200 mg/1)

Linked Drug Pages (1)

Guaifenesin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "209f74eb-400d-40fe-943e-cecd8aec3a1d", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ"], "rxcui": ["310621"], "spl_set_id": ["c3533119-b307-4bad-8c79-254fea08402b"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Aurohealth LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (58602-811-01)  / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "58602-811-01", "marketing_start_date": "20191021"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (58602-811-02)  / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "58602-811-02", "marketing_start_date": "20191021"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (58602-811-03)  / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "58602-811-03", "marketing_start_date": "20191021"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-811-05)  / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "58602-811-05", "marketing_start_date": "20191021"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-811-12)  / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "58602-811-12", "marketing_start_date": "20191021"}, {"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-811-21)", "package_ndc": "58602-811-21", "marketing_start_date": "20191021"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (58602-811-56)  / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "58602-811-56", "marketing_start_date": "20200131"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-811-57)  / 28 TABLET, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "58602-811-57", "marketing_start_date": "20191021"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-811-60)  / 42 TABLET, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "58602-811-60", "marketing_start_date": "20191021"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (58602-811-64)  / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "58602-811-64", "marketing_start_date": "20201126"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-811-73)  / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "58602-811-73", "marketing_start_date": "20191021"}], "brand_name": "Guaifenesin", "product_id": "58602-811_209f74eb-400d-40fe-943e-cecd8aec3a1d", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "58602-811", "generic_name": "Guaifenesin", "labeler_name": "Aurohealth LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "1200 mg/1"}], "application_number": "ANDA210453", "marketing_category": "ANDA", "marketing_start_date": "20191021", "listing_expiration_date": "20261231"}