robitussin maximum strength cough plus chest congestion dm

Generic: dextromethorphan hydrobromide and guaifenesin

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

Drug Facts

Product Profile

Brand Name robitussin maximum strength cough plus chest congestion dm
Generic Name dextromethorphan hydrobromide and guaifenesin
Labeler haleon us holdings llc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 10 mg/1, guaifenesin 200 mg/1

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0031-8719
Product ID 0031-8719_cb5018d5-8b32-41b8-a393-008d092d4638
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2027-12-31
Marketing Start 2013-05-23

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 00318719
Hyphenated Format 0031-8719

Supplemental Identifiers

RxCUI
1111663
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 cough plus chest congestion dm (source: ndc)
Generic Name dextromethorphan hydrobromide and guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
  • 200 mg/1
source: ndc
Packaging
  • 5 BLISTER PACK in 1 CARTON (0031-8719-10) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
  • 10 BLISTER PACK in 1 CARTON (0031-8719-20) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
source: ndc

Packages (2)

Ingredients (2)

dextromethorphan hydrobromide (10 mg/1) guaifenesin (200 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "cb5018d5-8b32-41b8-a393-008d092d4638", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1111663"], "spl_set_id": ["868ac65a-63e2-46ac-b87d-66b289086756"], "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": "5 BLISTER PACK in 1 CARTON (0031-8719-10)  / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "0031-8719-10", "marketing_start_date": "20160502"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (0031-8719-20)  / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "0031-8719-20", "marketing_start_date": "20130523"}], "brand_name": "Robitussin Maximum Strength Cough Plus Chest Congestion DM", "product_id": "0031-8719_cb5018d5-8b32-41b8-a393-008d092d4638", "dosage_form": "CAPSULE, LIQUID FILLED", "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": "0031-8719", "generic_name": "dextromethorphan hydrobromide and guaifenesin", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Robitussin Maximum Strength Cough Plus Chest Congestion DM", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}, {"name": "GUAIFENESIN", "strength": "200 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20130523", "listing_expiration_date": "20271231"}