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 66 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
topcare infants pain and fever	ACETAMINOPHEN	Topco Associates LLC	a1145ac3-3e55-4bd5-a53e-6cf869add9a1	2024-07-02	Warnings	Exact identifier application number: M013
Drug Mart Effervescent Pain Relief	ASPIRIN	Discount Drug Mart Inc	1c35f394-a221-6531-e063-6394a90acb8a	2024-07-01	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Wildman Business Group	cdbfcf14-8685-40a9-9778-a3b4329dc1ad	2024-07-01	Warnings	Exact identifier application number: M013
Back Pain Relief Extra Strength Doans	MAGNESIUM SALICYLATE	Wildman Business Group	2e17664f-a83f-48d1-8b2b-37f41eea65b6	2024-07-01	Warnings	Exact identifier application number: M013
Meijer Effervescent Pain Relief	ASPIRIN	Meijer Distribution Inc	17553911-e0fc-e355-e063-6394a90af7b8	2024-06-28	Warnings	Exact identifier application number: M013
leader childrens pain and fever	ACETAMINOPHEN	Cardinal Health 110, LLC. dba Leader	4fb4f4b2-c238-4933-b874-08def3b34a28	2024-06-26	Warnings	Exact identifier application number: M013
good neighbor pharmacy pain and fever childrens	ACETAMINOPHEN	Amerisource Bergen	ca0833ef-837b-47dc-8676-e016af96622c	2024-06-26	Warnings	Exact identifier application number: M013
leader childrens pain and fever	ACETAMINOPHEN	Cardinal Health 110, LLC. dba Leader	4a030c3e-8104-4a0a-98c5-6ab469451f20	2024-06-26	Warnings	Exact identifier application number: M013
Childrens Acetaminophen	ACETAMINOPHEN	Padagis Israel Pharmaceuticals Ltd	a426dd82-b2d6-405e-b0af-cfb1310a6e19	2024-06-26	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	WALMART INC. (see also Equate)	7d86a03f-74f4-4b24-b6a6-8747acfe905e	2024-06-26	Warnings	Exact identifier application number: M013
leader childrens pain and fever	ACETAMINOPHEN	Cardinal Health 110, LLC. dba Leader	5bcc5da9-7e64-4308-a5be-2f47a8ca774d	2024-06-25	Warnings	Exact identifier application number: M013
Codeine-Guaifenesin	CODEINE PHOSPHATE AND GUAIFENESIN	NuCare Pharmaceuticals,Inc.	9e691264-d48a-6b48-e053-2995a90a9352	2024-06-20	Warnings	Exact identifier application number: M013
Aspirin	REGULAR STRENGTH ENTERIC COATED ASPIRIN	NuCare Pharmceuticals,Inc.	a0705f4f-55cb-214a-e053-2995a90aa680	2024-06-20	Warnings	Exact identifier application number: M013
Extra Strength Pain Reliever	ACETAMINOPHEN 500 MG	Lil' Drug Store Products, Inc.	ee8e0e79-4da4-101f-e053-2a95a90a30a4	2024-06-19	Warnings	Exact identifier application number: M013
Extra Strength Headache Relief	ACETAMINOPHEN, ASPIRIN, AND CAFFEINE	Lil' Drug Store Products, Inc.	b3a06e4b-0b31-4e2a-8dd1-9de85760477b	2024-06-19	Warnings	Exact identifier application number: M013
pain relief	ACETAMINOPHEN	Meijer Distribution Inc	43c3fe72-a4ef-48a6-bc22-a644919c0c5c	2024-06-17	Warnings	Exact identifier application number: M013
Aspirin Regular Strength	ASPIRIN	RETAIL BUSINESS SERVICES , LLC.	093182a6-3ed8-5a3f-e063-6294a90a354a	2024-06-14	Warnings	Exact identifier application number: M013
ACETAMINOPHEN PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	093199be-e92a-6f60-e063-6294a90a8533	2024-06-14	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	RETAIL BUSINESS SERVICES , LLC.	09315a3d-bb2d-4f06-e063-6294a90a3bd3	2024-06-14	Warnings	Exact identifier application number: M013
Pain Relief Regular Strength	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION INC	613bc633-0426-41a7-aea9-9ff56311b607	2024-06-13	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