NDC 52389-153-01 - BackAid Max

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 52389-153
Requested NDC: 52389-153-01
Package NDCs from labels: 52389-153-01, 52389-153-28, 52389-153-14, 52389-153-03, 52389-153-38, 52389-153-46, 52389-153-35
Manufacturer: Kobayashi Healthcare International, Inc. | Kobayashi America Manufacturing, LLC
Effective date: 2025-04-14
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
BackAid	Kobayashi Healthcare International, Inc. \| Kobayashi America Manufacturing, LLC	2025-04-14	HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52389-153-01	BackAidMax	14 in 1 BLISTER PACK	TABLET, FILM COATED	14	14
52389-153-03	BackAidMax	38 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	38	14
52389-153-14	BackAidMax	1 in 1 CARTON	TABLET, FILM COATED	1	14
52389-153-28	BackAidMax	2 in 1 CARTON	TABLET, FILM COATED	2	14
52389-153-35	BackAidMax	5 in 1 CARTON	TABLET, FILM COATED	5	14
52389-153-35	BackAidMax	7 in 1 BLISTER PACK	TABLET, FILM COATED	7	14
52389-153-38	BackAidMax	1 in 1 CARTON	TABLET, FILM COATED	1	14
52389-153-46	BackAidMax	1 in 1 CARTON	TABLET, FILM COATED	1	14
52389-153-46	BackAidMax	46 in 1 BOTTLE	TABLET, FILM COATED	46	14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52389-153	BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.]	14	Current NDC, Legacy NDC, 9 package rows	20250416_fb9a5647-b7c9-4820-b148-91060e34cb83.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Acetaminophen	ACTIVE INGREDIENT	362O9ITL9D	BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	4
Pamabrom	ACTIVE INGREDIENT	UA8U0KJM72	BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	4
Acetaminophen	ACTIVE MOIETY	362O9ITL9D	BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	4
BROMOTHEOPHYLLINE	ACTIVE MOIETY	FZG87K1MQ6	BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	4
Calcium sulfate dihydrate	INACTIVE INGREDIENT	4846Q921YM	BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	4
Cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	4
Croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	4
D&C Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	4
FD&C Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	4
Magnesium oxide	INACTIVE INGREDIENT	3A3U0GI71G	BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	4
Magnesium silicate	INACTIVE INGREDIENT	9B9691B2N9	BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	4
Magnesium stearate	INACTIVE INGREDIENT	70097M6I30	BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	4
Mineral oil	INACTIVE INGREDIENT	T5L8T28FGP	BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	4
Polyethylene glycol 600	INACTIVE INGREDIENT	NL4J9F21N9	BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	4
Potassium gluconate	INACTIVE INGREDIENT	12H3K5QKN9	BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	4
Povidone	INACTIVE INGREDIENT	FZ989GH94E	BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	4
Sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	4
Sodium starch glycolate type a potato	INACTIVE INGREDIENT	5856J3G2A2	BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	4
Sorbitol	INACTIVE INGREDIENT	506T60A25R	BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	4
Starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	4
Stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	4
Titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	4

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 32 of 288 · 5,753 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucinex Fast-Max Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	27312ee4-d1f4-4a95-9c45-91fa5a01f5ba	2026-05-19	Warnings	Exact identifier unii: 362O9ITL9D
Mucinex Rapid Clear Daytime Pain, Headache, and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	37de53a7-5546-3804-e063-6294a90a0fb5	2026-05-19	Warnings	Exact identifier unii: 362O9ITL9D
Mucinex Fast-Max Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	36b07e49-c72c-45e5-e063-6394a90a804a	2026-05-19	Warnings	Exact identifier unii: 362O9ITL9D
Mucinex Fast-Max Congestion and Headache Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	d7017328-f8af-4601-9232-dc1104feaa0a	2026-05-19	Warnings	Exact identifier unii: 362O9ITL9D
Mucinex Rapid Clear Pain Headache and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	32375b12-75ed-d605-e063-6294a90ad004	2026-05-19	Warnings	Exact identifier unii: 362O9ITL9D
Mucinex Sinus-Max Pressure, Pain and Cough Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	07da45b5-d05e-41b1-b233-f7034d556a8d	2026-05-19	Warnings	Exact identifier unii: 362O9ITL9D
Mucinex Sinus-Max Severe Congestion and Pain Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	ad4e0e4d-cc1f-4176-835f-3ba76564c634	2026-05-19	Warnings	Exact identifier unii: 362O9ITL9D
Mucinex Childrens Mini Melts Cold and Flu	ACETAMINOPHEN AND GUAIFENESIN	Reckitt Benckiser LLC	401fe0a0-ec97-5248-e063-6394a90af27f	2026-05-19	Warnings	Exact identifier unii: 362O9ITL9D
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ST. MARY'S MEDICAL PARK PHARMACY	3d347b9b-1b5c-68c8-e063-6294a90aaa9b	2026-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 362O9ITL9D
Menstrual Complete	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	Topco Associates, LLC	62f03f3c-8475-40bd-a5e4-ec9292b74785	2026-05-19	Warnings	Exact identifier unii: 362O9ITL9D
GOOD SENSE DAYTIME	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	L. Perrigo Company	2597e84c-18b4-41a9-8e6a-ff0c4c1f0612	2026-05-18	Warnings	Exact identifier unii: 362O9ITL9D
Walgreens Headache Relief Extra Strength	ACETAMINOPHEN 250MG, ASPIRIN 250MG AND CAFFEINE 65MG	Walgreens	52109b65-3bf1-de38-e063-6394a90a9727	2026-05-18	Warnings	Exact identifier application number: M013 unii: 362O9ITL9D
Mucinex Childrens Night Time Multi-Symptom Cold	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	e048cd53-a3cd-484f-a972-4cb49791dba3	2026-05-18	Warnings	Exact identifier unii: 362O9ITL9D
Mucinex Childrens Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	5bda415d-739f-4ca5-b5b2-07c14a81863b	2026-05-18	Warnings	Exact identifier unii: 362O9ITL9D
Mucinex Childrens Multi-Symptom Cold and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	8f3eb5c5-832e-4806-b3da-ef112cf55dcf	2026-05-18	Warnings	Exact identifier unii: 362O9ITL9D
Mucinex Childrens FreeFrom Multi-Symptom Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	84e7be8f-2785-45ef-9c44-de05394fcd99	2026-05-18	Warnings	Exact identifier unii: 362O9ITL9D
Mucinex Childrens Fever Sore Throat and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	1538a75d-582a-9501-e063-6394a90a6c55	2026-05-18	Warnings	Exact identifier unii: 362O9ITL9D
MUCINEX FAST-MAX NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	3a24b06c-00a6-c2ef-e063-6294a90a4d72	2026-05-18	Warnings	Exact identifier unii: 362O9ITL9D
Genexa Infants Pain and Fever	ACETAMINOPHEN	Genexa Inc.	5220a40d-4a4f-5bad-e063-6394a90a93b0	2026-05-18	Warnings	Exact identifier application number: M013 unii: 362O9ITL9D
Menstrual Complete	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	Meijer Distribution, Inc.	14dd377f-1d30-4991-ad29-5ed1058d4622	2026-05-18	Warnings	Exact identifier unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.