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 66 of 287 · 5,739 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Night Time Cold and Flu ReadyInCase	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	P & L Development, LLC	e7dd763b-3005-4723-933b-171eb772afee	2026-01-29	Warnings	Exact identifier unii: 362O9ITL9D
Acetaminophen Extra Strength	ACETAMINOPHEN	FOODHOLD U.S.A., LLC	bc19bd47-69ea-4bcc-8d28-c043c9d32513	2026-01-29	Warnings	Exact identifier application number: M013 unii: 362O9ITL9D
Acetaminophen, Guaifenesin, Phenylephrine Hcl and Dextromethorphan HBr	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR	Softgel Healthcare Pvt Ltd	24bc9ae6-8e8f-c0a0-e063-6394a90a407f	2026-01-28	Warnings	Exact identifier unii: 362O9ITL9D
Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE	Softgel Healthcare Private Limited	229d1939-84a9-f18e-e063-6394a90aba30	2026-01-28	Warnings	Exact identifier unii: 362O9ITL9D
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE	SOFTGEL HEALTHCARE PRIVATE LIMITED	1fcbafaa-c871-db6d-e063-6394a90aab5e	2026-01-28	Warnings	Exact identifier unii: 362O9ITL9D
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE	SOFTGEL HEALTHCARE PRIVATE LIMITED	1f7a6375-ab66-9782-e063-6394a90a99f3	2026-01-28	Warnings	Exact identifier unii: 362O9ITL9D
ONESSIP ADULT NIGHTTIME SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI	MEDWISE LIFESCIENCES INC.	4970b8bc-3c7b-4b8a-e063-6294a90a7f1b	2026-01-28	Warnings	Exact identifier unii: 362O9ITL9D
SHISEIDO SPORTS BB DARK	OCTINOXATE AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	f4fc4b6a-9507-496e-9ecb-8400055ecf2d	2026-01-28	Warnings	Exact identifier unii: 15FIX9V2JP
Hampton Sun SPF 30 Mineral	ZINC OXIDE 7.20% TITANIUM DIOXIDE 4.00%	S&C Hampton Sun LLC	b8ee428e-07d3-4c6c-853c-cfbe3e4002d9	2026-01-28	Warnings	Exact identifier unii: 15FIX9V2JP
Alka-Seltzer Pain Relief	ALKA-SELTZER PAIN RELIEF	Bayer HealthCare LLC.	4975f0ff-0480-7fca-e063-6294a90aef2f	2026-01-28	Warnings	Exact identifier application number: M013
Extra Strength Mini Softgels Pain Reliever	ACETAMINOPHEN	THE KROGER CO	b49aae4f-b040-44a0-be73-cdf45cf14d7e	2026-01-28	Warnings	Exact identifier application number: M013 unii: 362O9ITL9D
Extra Strength Acetaminophen	ACETAMINOPHEN	Preferred Pharmaceuticals Inc.	b25faa8c-2d13-450a-970f-81c17a633030	2026-01-28	Warnings	Exact identifier application number: M013 unii: 362O9ITL9D
Daytime Cold and Flu Relief	ACETAMINOPHEN DEXTROMETHORPHAN HBR	Family Dollar (FAMILY WELLNESS)	fe3e74ba-31d9-4d50-ab61-ffb6aaa66085	2026-01-28	Warnings	Exact identifier unii: 362O9ITL9D
Leader Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Cardinal Health 110, LLC. dba Leader	9b1a5dbe-39dd-4dbb-800c-0cef422ae7c5	2026-01-28	Warnings	Exact identifier unii: 362O9ITL9D
Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	93d5b1db-e9ad-4a6a-b869-fd0d1a11df02	2026-01-27	Warnings	Exact identifier unii: 362O9ITL9D
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE	SOFTGEL HEALTHCARE PRIVATE LIMITED	37e8ccd5-6be1-9aca-e063-6394a90a5263	2026-01-27	Warnings	Exact identifier unii: 362O9ITL9D
Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE	SOFTGEL HEALTHCARE PRIVATE LIMITED	2f7f078e-de04-9d53-e063-6394a90a409f	2026-01-27	Warnings	Exact identifier unii: 362O9ITL9D
Pamabrom	PAMABROM	Softgel Healthcare Pvt Ltd	186805ed-84fc-e723-e063-6294a90ad320	2026-01-27	Warnings	Exact identifier unii: UA8U0KJM72
EXTRA STRENGTH ACETAMINOPHEN	ACETAMINOPHEN	Wal-Mart Stores Inc	a88eba4c-0701-4eec-9a24-a804186fbfd8	2026-01-27	Warnings	Exact identifier application number: M013 unii: 362O9ITL9D
EXTRA STRENGTH PAIN RELIEVER PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	WALMART INC.	649e0dd8-ca79-4bf1-9c15-9db9f1d2f5bd	2026-01-27	Warnings	Exact identifier application number: M013 unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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