Acetaminophen

Product NDC: 71205-165
11-digit product format: 712050165
Labeler code: 71205
Product ID: 71205-165_d52d213f-141d-4f01-87c7-0692e69dbc56
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-09-12
Substance: ACETAMINOPHEN
Active strength: 500 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
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: Acetaminophen
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198440	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
9af5ccc8-aac0-4339-a9f6-58fdc9b91c57	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71205-165-10	Acetaminophen	10 in 1 BOTTLE	TABLET	10	6
71205-165-24	Acetaminophen	24 in 1 BOTTLE	TABLET	24	6
71205-165-30	Acetaminophen	30 in 1 BOTTLE	TABLET	30	6
71205-165-40	Acetaminophen	40 in 1 BOTTLE	TABLET	40	6
71205-165-50	Acetaminophen	50 in 1 BOTTLE	TABLET	50	6
71205-165-60	Acetaminophen	60 in 1 BOTTLE	TABLET	60	6
71205-165-90	Acetaminophen	90 in 1 BOTTLE	TABLET	90	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71205-165-24	EA - Each	71205-165	7f8a9684-4acf-4ba5-b7da-ba6ea1e60006	1	2025-06-13
71205-165-30	EA - Each	71205-165	402348cf-a05c-48c0-9b00-9d20eccb2d96	1	2019-02-13
71205-165-40	EA - Each	71205-165	0082d262-8577-4eb6-830b-267630407a2f	1	2019-02-13
71205-165-50	EA - Each	71205-165	326b34d9-bf0f-4794-afa3-a3434df35ea2	1	2019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-165	ACETAMINOPHEN TABLET [PROFICIENT RX LP]	6	Current NDC, Legacy NDC, 7 package rows	20250501_9af5ccc8-aac0-4339-a9f6-58fdc9b91c57.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 7 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
INFANTS PAIN AND FEVER	ACETAMINOPHEN	Amazon.com Services LLC	112076c4-cac2-45ab-9c77-5573edae7180	2026-07-10	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Wal-Mart Stores Inc	8ae16aa2-54bc-4c1a-aa36-93524199a67b	2026-07-09	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Wildman Business Group	943c8f49-e65e-40bc-b364-3274df4d21a2	2026-07-09	Warnings	Exact identifier application number: M013
Aspirin Regular Strength	ASPIRIN	FOODHOLD U.S.A., LLC	9e09b4fb-e015-45ea-8b1c-27faf65572aa	2026-07-09	Warnings	Exact identifier application number: M013
Tension Headache Relief	ACETAMINOPHEN, CAFFEINE	Walgreen Company	f13fb7e9-50ea-4e2c-a442-38b1b5b315d7	2026-07-09	Warnings	Exact identifier application number: M013
Acetaminophen 500 Pyrilamine Maleate 15 and Caffeine 60	ACETAMINOPHEN 500MG PYRILAMINE MALEATE 15MG AND CAFFEINE 60MG TABLETS	Health Pharma USA LLC	34eb8a9b-d0ee-13e8-e063-6294a90a2fef	2026-07-08	Warnings	Exact identifier application number: M013
Acetaminophen 250 mg Aspirin 250 mg Caffeine 65 mg	ACETAMINOPHEN 250 MG ASPIRIN 250 MG CAFFEINE 65 MG	Health Pharma USA LLC	3590d417-272b-ae4d-e063-6394a90a5dc6	2026-07-08	Warnings	Exact identifier application number: M013
GOODMEDS EXTRA STRENGTH PAIN RELIEF ACETAMINOPHEN	ACETAMINOPHEN	Cabinet Health P.B.C.	88884253-5a79-4ac1-b8ce-03966d8b509d	2026-07-08	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Health Pharma USA LLC	671adabe-5f82-4599-a133-3f67ccb34079	2026-07-07	Warnings	Exact identifier application number: M013
Pain Reliever Plus	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Rugby Laboratories	c3df1652-96a8-6043-e053-2995a90a2d26	2026-07-07	Warnings	Exact identifier application number: M013
Rapidol Aspirin	ASPIRIN	Pharmadel LLC	00d9ab0d-ff25-784f-e063-6294a90a8497	2026-07-06	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Trifecta Pharmaceuticals USA LLC	227cefca-acc4-41d0-e063-6394a90a35b9	2026-07-06	Warnings	Exact identifier application number: M013
Extra Strength Pain Aid	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Hi-Tech Nutaceuticals, LLC	a39e4b99-700d-0f5c-e053-2a95a90a6bd3	2026-07-06	Warnings	Exact identifier application number: M013
Nighttime Sleep Aid	ACETAMINOPHEN, DIPHENHYDRAMINE	Hi-Tech Nutraceuticals, LLC	a39e2bd6-3d0a-642b-e053-2995a90a42a0	2026-07-06	Warnings	Exact identifier application number: M013
Extra Strength Acetaminophen	ACETAMINOPHEN	Hi-Tech Nutraceuticals, LLC	a36be487-7a36-550f-e053-2a95a90a95c1	2026-07-06	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Hi-Tech Nutraceuticals, LLC	a39c524e-c131-d7fb-e053-2995a90a785b	2026-07-06	Warnings	Exact identifier application number: M013
PAIN RELIEVER	ASPIRIN 81 MG	Health Pharma USA, LLC	d60aed37-3a9e-46d1-e053-2995a90a1d1f	2026-07-06	Warnings	Exact identifier application number: M013
Tylenol PM Extra Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	Select Consumer Group	55d0dceb-c9a9-778e-e063-6294a90a2ad7	2026-07-04	Warnings	Exact identifier application number: M013
Bayer Genuine Aspirin	ASPIRIN	Select Consumer Group	3ca776c2-47ed-5107-e063-6394a90ac5df	2026-07-03	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Rugby Laboratories	f7ca9f4a-f8ef-46d2-9536-b69541e6653d	2026-07-02	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198440	acetaminophen 500 MG Oral Tablet	PSN	9af5ccc8-aac0-4339-a9f6-58fdc9b91c57	6
198440	acetaminophen 500 MG Oral Tablet	SCD	9af5ccc8-aac0-4339-a9f6-58fdc9b91c57	6
198440	APAP 500 MG Oral Tablet	SY	9af5ccc8-aac0-4339-a9f6-58fdc9b91c57	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-165-10	71205016510	10 TABLET in 1 BOTTLE (71205-165-10)	10 tablet	2018-12-01	0000-00-00	No	No	Current
71205-165-24	71205016524	24 TABLET in 1 BOTTLE (71205-165-24)	24 tablet	2025-04-24		No	No	Current
71205-165-30	71205016530	30 TABLET in 1 BOTTLE (71205-165-30)	30 tablet	2018-12-01	0000-00-00	No	No	Current
71205-165-40	71205016540	40 TABLET in 1 BOTTLE (71205-165-40)	40 tablet	2018-12-01	0000-00-00	No	No	Current
71205-165-50	71205016550	50 TABLET in 1 BOTTLE (71205-165-50)	50 tablet	2018-12-01	0000-00-00	No	No	Current
71205-165-60	71205016560	60 TABLET in 1 BOTTLE (71205-165-60)	60 tablet	2018-12-01	0000-00-00	No	No	Current
71205-165-90	71205016590	90 TABLET in 1 BOTTLE (71205-165-90)	90 tablet	2018-12-01	0000-00-00	No	No	Current