robitussin direct sore throat pain

Generic: acetaminophen

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

Drug Facts

Product Profile

Brand Name robitussin direct sore throat pain
Generic Name acetaminophen
Labeler haleon us holdings llc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

acetaminophen 500 mg/1

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0031-9301
Product ID 0031-9301_159c0477-cdc8-fbc7-e063-6294a90a3448
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2022-07-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00319301
Hyphenated Format 0031-9301

Supplemental Identifiers

RxCUI
198440
UNII
362O9ITL9D

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 direct sore throat pain (source: ndc)
Generic Name acetaminophen (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 18 TABLET, COATED in 1 BOTTLE (0031-9301-01)
source: ndc

Packages (1)

0031-9301-01 18 TABLET, COATED in 1 BOTTLE (0031-9301-01)

Ingredients (1)

acetaminophen (500 mg/1)

Linked Drug Pages (1)

Robitussin Direct Sore Throat Pain ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "159c0477-cdc8-fbc7-e063-6294a90a3448", "openfda": {"unii": ["362O9ITL9D"], "rxcui": ["198440"], "spl_set_id": ["1b512078-24c3-4b80-8f2c-d6824d367f25"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "18 TABLET, COATED in 1 BOTTLE (0031-9301-01)", "package_ndc": "0031-9301-01", "marketing_start_date": "20220715"}], "brand_name": "Robitussin Direct Sore Throat Pain", "product_id": "0031-9301_159c0477-cdc8-fbc7-e063-6294a90a3448", "dosage_form": "TABLET, COATED", "product_ndc": "0031-9301", "generic_name": "acetaminophen", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Robitussin Direct Sore Throat Pain", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "500 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20220715", "listing_expiration_date": "20261231"}