robitussin maximum strength 12 hour cough and mucus relief

Generic: dextromethorphan hydrobromide, guaifenesin

Labeler: haleon us holdings llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name robitussin maximum strength 12 hour cough and mucus relief
Generic Name dextromethorphan hydrobromide, guaifenesin
Labeler haleon us holdings llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

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

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0031-8765
Product ID 0031-8765_158a1612-05f6-cc2e-e063-6294a90ab9ef
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA207602
Listing Expiration 2026-12-31
Marketing Start 2019-06-14

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 00318765
Hyphenated Format 0031-8765

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 robitussin maximum strength 12 hour cough and mucus relief (source: ndc)
Generic Name dextromethorphan hydrobromide, guaifenesin (source: ndc)
Application Number ANDA207602 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
  • 1200 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (0031-8765-04) / 4 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (0031-8765-08) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (0031-8765-16) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (3)

0031-8765-04 1 BLISTER PACK in 1 CARTON (0031-8765-04) / 4 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 0031-8765-08 1 BLISTER PACK in 1 CARTON (0031-8765-08) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 0031-8765-16 2 BLISTER PACK in 1 CARTON (0031-8765-16) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (2)

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

Linked Drug Pages (1)

Robitussin Maximum Strength 12 Hour Cough and Mucus Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "158a1612-05f6-cc2e-e063-6294a90ab9ef", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1099074"], "spl_set_id": ["96409b52-b0ec-444b-bc39-fd41070e9855"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (0031-8765-04)  / 4 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "0031-8765-04", "marketing_start_date": "20190614"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (0031-8765-08)  / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "0031-8765-08", "marketing_start_date": "20190614"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (0031-8765-16)  / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "0031-8765-16", "marketing_start_date": "20190614"}], "brand_name": "Robitussin Maximum Strength 12 Hour Cough and Mucus Relief", "product_id": "0031-8765_158a1612-05f6-cc2e-e063-6294a90ab9ef", "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": "0031-8765", "generic_name": "Dextromethorphan Hydrobromide, Guaifenesin", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Robitussin Maximum Strength 12 Hour Cough and Mucus Relief", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "60 mg/1"}, {"name": "GUAIFENESIN", "strength": "1200 mg/1"}], "application_number": "ANDA207602", "marketing_category": "ANDA", "marketing_start_date": "20190614", "listing_expiration_date": "20261231"}