Home NDC 0031-8752 Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime
Product NDC 0031-8752
11-digit product format 000318752
Labeler code 0031
Product ID 0031-8752_156ef02d-2284-6dc7-e063-6294a90a3be9
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Haleon US Holdings LLC
Application M0012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-07-01
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 650; 25; 10 mg/20mL; mg/20mL; mg/20mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 650 mg/20mL DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/20mL PHENYLEPHRINE HYDROCHLORIDE 10 mg/20mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup TC2D6JAD40 Internal UNII lookup 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1375932 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0031-8752-12 Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime 118 mL in 1 BOTTLE SOLUTION 118 9 0031-8752-12 Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime 1 in 1 CARTON SOLUTION 1 9 0031-8752-18 Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime 237 mL in 1 BOTTLE SOLUTION 237 9 0031-8752-18 Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime 1 in 1 CARTON SOLUTION 1 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D ROBITUSSIN SEVERE MULTI-SYMPTOM COUGH COLD FLU NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RICHMOND DIVISION OF WYETH] 1 DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 ROBITUSSIN SEVERE MULTI-SYMPTOM COUGH COLD FLU NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RICHMOND DIVISION OF WYETH] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ ROBITUSSIN SEVERE MULTI-SYMPTOM COUGH COLD FLU NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RICHMOND DIVISION OF WYETH] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D ROBITUSSIN SEVERE MULTI-SYMPTOM COUGH COLD FLU NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RICHMOND DIVISION OF WYETH] 1 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M ROBITUSSIN SEVERE MULTI-SYMPTOM COUGH COLD FLU NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RICHMOND DIVISION OF WYETH] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV ROBITUSSIN SEVERE MULTI-SYMPTOM COUGH COLD FLU NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RICHMOND DIVISION OF WYETH] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL ROBITUSSIN SEVERE MULTI-SYMPTOM COUGH COLD FLU NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RICHMOND DIVISION OF WYETH] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K ROBITUSSIN SEVERE MULTI-SYMPTOM COUGH COLD FLU NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RICHMOND DIVISION OF WYETH] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ROBITUSSIN SEVERE MULTI-SYMPTOM COUGH COLD FLU NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RICHMOND DIVISION OF WYETH] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ROBITUSSIN SEVERE MULTI-SYMPTOM COUGH COLD FLU NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RICHMOND DIVISION OF WYETH] 1 MENTHOL, UNSPECIFIED FORM INACTIVE INGREDIENT L7T10EIP3A ROBITUSSIN SEVERE MULTI-SYMPTOM COUGH COLD FLU NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RICHMOND DIVISION OF WYETH] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ROBITUSSIN SEVERE MULTI-SYMPTOM COUGH COLD FLU NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RICHMOND DIVISION OF WYETH] 1 PROPYL GALLATE INACTIVE INGREDIENT 8D4SNN7V92 ROBITUSSIN SEVERE MULTI-SYMPTOM COUGH COLD FLU NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RICHMOND DIVISION OF WYETH] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ROBITUSSIN SEVERE MULTI-SYMPTOM COUGH COLD FLU NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RICHMOND DIVISION OF WYETH] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU ROBITUSSIN SEVERE MULTI-SYMPTOM COUGH COLD FLU NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RICHMOND DIVISION OF WYETH] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR ROBITUSSIN SEVERE MULTI-SYMPTOM COUGH COLD FLU NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RICHMOND DIVISION OF WYETH] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R ROBITUSSIN SEVERE MULTI-SYMPTOM COUGH COLD FLU NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RICHMOND DIVISION OF WYETH] 1 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 ROBITUSSIN SEVERE MULTI-SYMPTOM COUGH COLD FLU NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RICHMOND DIVISION OF WYETH] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ROBITUSSIN SEVERE MULTI-SYMPTOM COUGH COLD FLU NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RICHMOND DIVISION OF WYETH] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0031-8752 ROBITUSSIN SEVERE MULTI-SYMPTOM COUGH COLD FLU NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [HALEON US HOLDINGS LLC] 9 Current NDC, Legacy NDC, 4 package rows 20240408_89360fa8-014d-4da8-bb1c-197e3aa52256.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0031-8752-12 00031875212 1 BOTTLE in 1 CARTON (0031-8752-12) / 118 mL in 1 BOTTLE 1 bottle 2015-07-01 0000-00-00 No No Current 0031-8752-18 00031875218 1 BOTTLE in 1 CARTON (0031-8752-18) / 237 mL in 1 BOTTLE 1 bottle 2015-07-01 0000-00-00 No No Current