NDC 55316-964

Healthy Accents Severe Cold

Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride

Healthy Accents Severe Cold is a Oral Powder, For Solution in the Human Otc Drug category. It is labeled and distributed by Dza Brands Llc. The primary component is Acetaminophen; Diphenhydramine Hydrochloride; Phenylephrine Hydrochloride.

Product ID55316-964_39e8b868-ed1d-4e14-bb58-79eddf0cc64a
NDC55316-964
Product TypeHuman Otc Drug
Proprietary NameHealthy Accents Severe Cold
Generic NameAcetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride
Dosage FormPowder, For Solution
Route of AdministrationORAL
Marketing Start Date2015-09-17
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameDZA Brands LLC
Substance NameACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength650 mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 55316-964-91

6 POWDER, FOR SOLUTION in 1 CARTON (55316-964-91)
Marketing Start Date2015-09-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55316-964-91 [55316096491]

Healthy Accents Severe Cold POWDER, FOR SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-09-17

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN650 mg/1

OpenFDA Data

SPL SET ID:462201fd-4ed2-4982-a2df-7d203d3c0409
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1659960

    • NDC Crossover Matching brand name "Healthy Accents Severe Cold" or generic name "Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    55316-964Healthy Accents Severe ColdHealthy Accents Severe Cold
    10202-9647 select night time severe cold cough and fluAcetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
    41520-483CareOne Nighttime Severe Cold and CoughAcetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
    0031-2249Childrens Dimetapp Multi-Symptom Cold and Fluacetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride
    41163-964equaline flu and severe cold and coughAcetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
    30142-964flu and severe cold and coughAcetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
    37808-807Flu and Severe Cold and CoughAcetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
    41250-964flu and severe cold and coughAcetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
    30142-317Flu Relief Therapy Severe Cough and ColdAcetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride
    0113-0964good sense flu and severe cold and coughAcetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
    30142-949night time cold and fluacetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride
    0031-8752Robitussin Severe Multi-Symptom Cough Cold Flu Nighttimeacetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride
    11822-0964severe cold cough and flu reliefAcetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
    37808-543severe cold, flu and coughAcetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
    21130-020Signature Care severe cold cough and fluAcetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
    0067-8124Theraflu Nighttime Multi-Symptom Severe Cold PowderAcetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride
    36800-964topcare flu and severe cold and coughAcetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
    0363-0964wal flu severe cold and coughAcetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.