BackAid

Product NDC: 52389-153
11-digit product format: 523890153
Labeler code: 52389
Product ID: 52389-153_32c0bf9d-154f-e502-e063-6294a90a0b35
Type: HUMAN OTC DRUG
Nonproprietary name: acetaminophen, pamabrom
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Kobayashi Healthcare International, Inc.
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1992-02-01
Substance: ACETAMINOPHEN; PAMABROM
Active strength: 500; 25 mg/1; mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: BackAid
Brand name suffix: Max
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	500 mg/1
PAMABROM	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
UA8U0KJM72	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198449	Internal RxNorm lookup
1356080	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
fb9a5647-b7c9-4820-b148-91060e34cb83	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125

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 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

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

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 77 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sanatos Multi Symptom Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI	Pharmadel LLC	0ab11691-5b29-55fc-e063-6394a90aa328	2023-11-17	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	A-S Medication Solutions	1e223faa-f6d0-4235-bc4c-6cfca84a5b0a	2023-11-17	Warnings	Exact identifier application number: M013
SanaTos X	ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCI	Pharmadel LLC	85b8ef3d-7318-7f3b-e053-2991aa0a0777	2023-11-14	Warnings	Exact identifier application number: M013
RIGHT REMEDIES EXTRA STRENGTH PM Pain Relief	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	8badbaad-eb35-4251-a779-00474819360d	2023-11-13	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Trifecta Pharmaceuticals USA LLC	09935a74-34b0-0e7c-e063-6294a90a7c83	2023-11-07	Warnings	Exact identifier application number: M013
Pain Relief PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	AMERIFOODS TRADING COMPANY	f6dd6396-93e9-1096-e053-6394a90af06d	2023-11-02	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	RETAIL BUSINESS SERVICES , LLC.	eb644e9e-36dc-5f84-e053-2a95a90affa5	2023-11-02	Warnings	Exact identifier application number: M013
Good Sense Childrens Pain and Fever	ACETAMINOPHEN	Proficient Rx LP	46527b1f-7515-44ce-b5cb-9d24223b9af1	2023-11-01	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	A-S Medication Solutions	12feb32b-4b8c-4b17-9e86-cb286457b088	2023-11-01	Warnings	Exact identifier application number: M013
Acetaminophen, Aspirin, Caffeine	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Proficient Rx LP	af8b30a0-7a56-4557-8404-cc8059fcd6bc	2023-11-01	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	AMERIFOODS TRADING COMPANY	f6dd387d-c768-9443-e053-6394a90aca14	2023-10-31	Warnings	Exact identifier application number: M013
ASPIRIN	ASPIRIN	AMERIFOODS TRADING COMPANY	f6cec280-17a5-5c5d-e053-6394a90a81aa	2023-10-31	Warnings	Exact identifier application number: M013
Regular Strength Aspirin	ASPIRIN	CARDINAL HEALTH, INC.	8aaa82c6-b46b-25c5-e053-2a95a90a3793	2023-10-30	Warnings	Exact identifier application number: M013
SafeTynadol	ACETAMINOPHEN	Sinew Pharma Inc.	b956d527-7ea7-e084-e053-2a95a90a866d	2023-10-28	Warnings	Exact identifier application number: M013
Pain Reliever PM	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	Magno-Humphries, Inc.	9d2275c8-0c3d-d2b3-e053-2995a90a368e	2023-10-27	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	Magno-Humphries, Inc.	9d22bedb-9fb3-8421-e053-2a95a90acf4a	2023-10-27	Warnings	Exact identifier application number: M013
Acetaminophen Regular Strength	ACETAMINOPHEN	Magno-Humphries, Inc.	9d22d642-8aaf-d17e-e053-2995a90ae182	2023-10-27	Warnings	Exact identifier application number: M013
ENTERIC COATED ASPIRIN	ASPIRIN	Magno-Humphries, Inc.	a7c02378-4213-4e57-aca2-2437ad02f786	2023-10-27	Warnings	Exact identifier application number: M013
Extraprin	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Magno-Humphries, Inc.	9d22cdc8-29c5-4273-e053-2a95a90ad0bf	2023-10-27	Warnings	Exact identifier application number: M013
Regular Strength Enteric coated aspirin	ASPIRIN	Geri-Care Pharmaceutical Corp	c321208c-f192-42c5-9454-e0df5d02d685	2023-10-26	Warnings	Exact identifier application number: M013

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
UA8U0KJM72	PAMABROM	606-04-2	PAMABROM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198449	acetaminophen 500 MG / pamabrom 25 MG Oral Tablet	PSN	fb9a5647-b7c9-4820-b148-91060e34cb83	14
1356080	BACKAID MAX EXTRA STRENGTH 500 MG / 25 MG 6HR Oral Tablet	PSN	fb9a5647-b7c9-4820-b148-91060e34cb83	14
1356080	acetaminophen 500 MG / pamabrom 25 MG Oral Tablet [Backaid]	SBD	fb9a5647-b7c9-4820-b148-91060e34cb83	14
198449	acetaminophen 500 MG / pamabrom 25 MG Oral Tablet	SCD	fb9a5647-b7c9-4820-b148-91060e34cb83	14
198449	APAP 500 MG / pamabrom 25 MG Oral Tablet	SY	fb9a5647-b7c9-4820-b148-91060e34cb83	14
1356080	APAP 500 MG / pamabrom 25 MG Oral Tablet [Backaid]	SY	fb9a5647-b7c9-4820-b148-91060e34cb83	14
1356080	Backaid (acetaminophen 500 MG / pamabrom 25 mg) oral tablet	SY	fb9a5647-b7c9-4820-b148-91060e34cb83	14
1356080	Backaid (APAP 500 MG / pamabrom 25 mg) oral tablet	SY	fb9a5647-b7c9-4820-b148-91060e34cb83	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52389-153-01	52389015301	14 in 1 BLISTER PACK						Historical
52389-153-03	52389015303	38 in 1 BOTTLE, PLASTIC						Historical
52389-153-14	52389015314	1 BLISTER PACK in 1 CARTON (52389-153-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK (52389-153-01)	1 blister pack	2011-06-01	0000-00-00	No	No	Current
52389-153-28	52389015328	2 BLISTER PACK in 1 CARTON (52389-153-28) / 14 TABLET, FILM COATED in 1 BLISTER PACK (52389-153-01)	2 blister pack	2011-03-01	0000-00-00	No	No	Current
52389-153-35	52389015335	5 BLISTER PACK in 1 CARTON (52389-153-35) / 7 TABLET, FILM COATED in 1 BLISTER PACK	5 blister pack	2011-06-01	0000-00-00	No	No	Current
52389-153-38	52389015338	1 BOTTLE, PLASTIC in 1 CARTON (52389-153-38) / 38 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (52389-153-03)		2010-09-01	0000-00-00	No	No	Current
52389-153-46	52389015346	1 BOTTLE in 1 CARTON (52389-153-46) / 46 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2016-04-29	0000-00-00	No	No	Current

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