respiratory relief

Generic: guaifenesin

Labeler: schwabe north america, inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name respiratory relief
Generic Name guaifenesin
Labeler schwabe north america, inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

guaifenesin 400 mg/1

Manufacturer
Schwabe North America, Inc

Identifiers & Regulatory

Product NDC 53499-5295
Product ID 53499-5295_6465861b-e970-4f26-8c90-2ee4a6323723
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-07-29

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 534995295
Hyphenated Format 53499-5295

Supplemental Identifiers

RxCUI
359601
UPC
0033674152959
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 respiratory relief (source: ndc)
Generic Name guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (53499-5295-0)
source: ndc

Packages (1)

53499-5295-0 30 TABLET in 1 BOTTLE (53499-5295-0)

Ingredients (1)

guaifenesin (400 mg/1)

Linked Drug Pages (1)

Respiratory Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6465861b-e970-4f26-8c90-2ee4a6323723", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0033674152959"], "unii": ["495W7451VQ"], "rxcui": ["359601"], "spl_set_id": ["f683041a-4ff9-42a5-9047-a9a3140a8758"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Schwabe North America, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (53499-5295-0)", "package_ndc": "53499-5295-0", "marketing_start_date": "20250729"}], "brand_name": "Respiratory Relief", "product_id": "53499-5295_6465861b-e970-4f26-8c90-2ee4a6323723", "dosage_form": "TABLET", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "53499-5295", "generic_name": "GUAIFENESIN", "labeler_name": "Schwabe North America, Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Respiratory Relief", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "400 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250729", "listing_expiration_date": "20261231"}