guaifenesin and dextromethorphan hydrobromide (51316-600)

Drug Facts

Product Profile

Brand Name guaifenesin and dextromethorphan hydrobromide

Generic Name guaifenesin and dextromethorphan hydrobromide

Labeler cvs pharmacy, inc

Dosage Form TABLET, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

dextromethorphan hydrobromide 60 mg/1, guaifenesin 1200 mg/1

Manufacturer

CVS PHARMACY, INC

Identifiers & Regulatory

Product NDC 51316-600

Product ID 51316-600_43f2e9e3-4aff-a93d-e063-6294a90a2286

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA214781

Listing Expiration 2026-12-31

Marketing Start 2022-04-19

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 51316600

Hyphenated Format 51316-600

Supplemental Identifiers

RxCUI

1099074

UNII

9D2RTI9KYH 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 and dextromethorphan hydrobromide (source: ndc)

Generic Name guaifenesin and dextromethorphan hydrobromide (source: ndc)

Application Number ANDA214781 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

60 mg/1
1200 mg/1

source: ndc

Packaging

5 BLISTER PACK in 1 CARTON (51316-600-70) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

source: ndc

Packages (1)

51316-600-70 5 BLISTER PACK in 1 CARTON (51316-600-70) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (2)

dextromethorphan hydrobromide (60 mg/1) guaifenesin (1200 mg/1)

Linked Drug Pages (1)

Guaifenesin and Dextromethorphan Hydrobromide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "43f2e9e3-4aff-a93d-e063-6294a90a2286", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1099074"], "spl_set_id": ["dd00dfc0-e523-4dec-8fc0-50363eadec57"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["CVS PHARMACY, INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 BLISTER PACK in 1 CARTON (51316-600-70)  / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "51316-600-70", "marketing_start_date": "20220419"}], "brand_name": "Guaifenesin and Dextromethorphan Hydrobromide", "product_id": "51316-600_43f2e9e3-4aff-a93d-e063-6294a90a2286", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "51316-600", "generic_name": "Guaifenesin and Dextromethorphan Hydrobromide", "labeler_name": "CVS PHARMACY, INC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin and Dextromethorphan Hydrobromide", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "60 mg/1"}, {"name": "GUAIFENESIN", "strength": "1200 mg/1"}], "application_number": "ANDA214781", "marketing_category": "ANDA", "marketing_start_date": "20220419", "listing_expiration_date": "20261231"}