NDC 0031-8752

Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime

Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride

Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The primary component is Acetaminophen; Diphenhydramine Hydrochloride; Phenylephrine Hydrochloride.

• Product ID: 0031-8752_35430576-fbee-4431-9641-4f97e9f09284
• NDC: 0031-8752
• Product Type: Human Otc Drug
• Proprietary Name: Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime
• Generic Name: Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2015-07-01
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
• Substance Name: ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 650 mg/20mL; mg/20mL; mg/20mL
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0031-8752-12

1 BOTTLE in 1 CARTON (0031-8752-12) > 118 mL in 1 BOTTLE

• Marketing Start Date: 2015-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0031-8752-18 [00031875218]

Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime SOLUTION

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-07-01

NDC 0031-8752-12 [00031875212]

Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime SOLUTION

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-07-01

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	650 mg/20mL

OpenFDA Data

• SPL SET ID: 89360fa8-014d-4da8-bb1c-197e3aa52256
• Manufacturer:
  • Richmond Division of Wyeth
• UNII:
  • TC2D6JAD40
  • 362O9ITL9D
  • 04JA59TNSJ
• RxNorm Concept Unique ID - RxCUI:
  • 1375932

NDC Crossover Matching brand name "Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime" or generic name "Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
0031-8752	Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime	acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride
10202-964	7 select night time severe cold cough and flu	Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
41520-483	CareOne Nighttime Severe Cold and Cough	Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
0031-2249	Childrens Dimetapp Multi-Symptom Cold and Flu	acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride
41163-964	equaline flu and severe cold and cough	Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
30142-964	flu and severe cold and cough	Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
37808-807	Flu and Severe Cold and Cough	Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
41250-964	flu and severe cold and cough	Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
30142-317	Flu Relief Therapy Severe Cough and Cold	Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride
0113-0964	good sense flu and severe cold and cough	Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
30142-949	night time cold and flu	acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride
11822-0964	severe cold cough and flu relief	Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
37808-543	severe cold, flu and cough	Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
21130-020	Signature Care severe cold cough and flu	Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
0067-8124	Theraflu Nighttime Multi-Symptom Severe Cold Powder	Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride
36800-964	topcare flu and severe cold and cough	Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
0363-0964	wal flu severe cold and cough	Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride