Acetaminophen

Product NDC: 68071-3454
11-digit product format: 680713454
Labeler code: 68071
Product ID: 68071-3454_404529fa-4eba-d862-e063-6394a90a08b9
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-03-11
Substance: ACETAMINOPHEN
Active strength: 325 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 32 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-3454-4	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-3454-3	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-3454-5	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-3454-4	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-3454-3	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-3454-5	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-3454-4	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-3454-3	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-3454-5	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-3454-4	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-3454-3	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-3454-5	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-3454-4	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-3454-3	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-3454-5	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-3454-5	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-3454-3	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-3454-4	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-3454-5	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-3454-3	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-3454-4	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-3454-5	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-3454-3	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-3454-4	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	325 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
313782	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
004c39cd-b4f4-1cae-e063-6394a90a0697	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
75d4bef7-334c-4a95-abb5-bff9def24114	Product name	2	20260112
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7f	Product name	5	20250115
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
88300afc-e1c4-ad17-c80b-4957f1b809a5	Product name	5	20250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043	Product name	7	20240611
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66f	Product name	1	20230808
a3631b20-02d1-41d7-8187-5e5e850b9e80	Product name	1	20230306
79e1734e-f721-4d46-978a-be382f771672	Product name	2	20230110
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6	Product name	9	20220921
92ead9ae-674d-4eee-a492-c385d496891f	Product name	3	20220308
103b151b-b17f-42ac-8624-3ef62f5e2975	Product name	2	20200507
b8497372-efe9-9dde-fa2d-59be9761aa64	Product name	9	20200428
20c8cafe-5cfc-44f8-a9be-a664f437f780	Product name	2	20200225
3a16d77a-e865-468a-aedf-6e58913c1c21	Product name	3	20190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880	Product name	1	20190320
00d531e4-b130-8c52-eaf9-826cbb6f15dd	Product name	3	20190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659	Product name	9	20190205
22d922aa-c443-d9f3-b23c-03b03a9ad31c	Product name	7	20181220
377068df-225f-7318-a910-a1987cdfa361	Product name	3	20170608
23475c0b-a5b5-4fec-b97f-acca901eae6a	Product name	1	20140718
105ef617-6fa4-6713-326f-72ec8a6b75a9	Product name	1	20140508
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
3ed6b849-48b8-8899-c288-6eeb396123b6	Product name	1	20140508
47fd879b-91c5-e1e5-130f-29d082a871ec	Product name	1	20140508
53855190-7124-8179-f018-e792f7c27f28	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0	Product name	1	20140508
96c5169b-5b9d-547d-bf22-d688d91866e4	Product name	1	20140508
b8e0daf1-fb81-290b-c0bf-873be19ef775	Product name	1	20140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00	Product name	1	20140508
c8753a88-edde-8e17-a396-705537b52cee	Product name	1	20140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ce	Product name	1	20140508
cf3a804d-0326-aa22-0142-c184b5657d85	Product name	1	20140508
d83c592c-dd97-4cbf-36ac-13da806684bd	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
68071-3454-3	2025-10-03	Drug Facts
68071-3454-4	2025-10-03	Drug Facts
68071-3454-5	2025-10-03	Drug Facts
68071-3454-3	2025-01-30	Drug Facts
68071-3454-4	2025-01-30	Drug Facts
68071-3454-5	2025-01-30	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68071-3454-3	Acetaminophen	30 in 1 BOTTLE, PLASTIC	TABLET	30	5
68071-3454-4	Acetaminophen	40 in 1 BOTTLE, PLASTIC	TABLET	40	5
68071-3454-5	Acetaminophen	50 in 1 BOTTLE, PLASTIC	TABLET	50	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3454	ACETAMINOPHEN TABLET [NUCARE PHARMACEUTICALS,INC.]	4	Current NDC, 3 package rows	20230929_004c39cd-b4f4-1cae-e063-6394a90a0697.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 40 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Medique at Home APAP Extra Strength	ACETAMINOPHEN 500 MG	Unifirst First Aid Corporation	b56b4110-fb8f-e5a0-e053-2995a90a0ad3	2025-09-08	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	P & L Development, LLC	64c642b7-ef83-44b7-a014-6fa248dff3ba	2025-09-08	Warnings	Exact identifier application number: M013
Extra Strength Acetaminophen PM	ACETAMINOPHEN, DIPHENHYDRAMINE	BJWC (Berkley & Jensen / BJ's)	2f473f1f-7cf3-2af5-e063-6394a90aaa17	2025-09-01	Warnings	Exact identifier application number: M013
foster and thrive rapid release pain relief	ACETAMINOPHEN	Strategic Sourcing Services LLC	d2130173-b107-4ae6-a1f7-6db467da3820	2025-08-30	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Precision Dose, Inc.	e1d4f562-433c-4344-9b77-1a7c731d1be5	2025-08-29	Warnings	Exact identifier application number: M013
Aspirin Enteric Coated Low Dose	ASPIRIN	Walgreen Company	b11a4c4e-374c-403e-a757-5e9700f9f03b	2025-08-27	Warnings	Exact identifier application number: M013
pain relief	ACETAMINOPHEN	Safeway	0e0a73f9-8c18-41fd-812e-8be20287e77a	2025-08-26	Warnings	Exact identifier application number: M013
Aspirin Low Dose Safety Coated	ASPIRIN	BJWC (Berkley & Jensen / BJ's)	577035a5-88ab-431c-8598-7a19dd633fe9	2025-08-26	Warnings	Exact identifier application number: M013
Topcare Pain Relief	ACETAMINOPHEN	Sixarp, LLC	2e20be17-2b6c-1a07-e063-6394a90acdd3	2025-08-25	Warnings	Exact identifier application number: M013
Low Dose Aspirin	ASPIRIN	BJWC (Berkley & Jensen / BJ's)	2f32b096-d29a-c7c7-e063-6294a90a2bbe	2025-08-22	Warnings	Exact identifier application number: M013
Medique Medi Seltzer	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Unifirst First Aid Corporation	528da9d9-2a52-4c16-b7b2-61b3eee1abea	2025-08-19	Warnings	Exact identifier application number: M013
pain relief	ACETAMINOPHEN	Publix Super Markets Inc	6b691dc1-09e4-46d3-b199-8917e42848a6	2025-08-19	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	P & L Development, LLC	59eb14a5-40b0-4331-beb5-7166e6cdf411	2025-08-18	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	PAI Holdings, LLC dba PAI Pharma	caf5daea-409e-5dd2-e053-2995a90acb12	2025-08-18	Warnings	Exact identifier application number: M013
Dr Simi Pain Relief 100	ACETAMINOPHEN	Farmacias De Similares TX LLC	3c42e48d-cdb2-eb74-e063-6394a90a2940	2025-08-13	Warnings	Exact identifier application number: M013
Dr Simi Pain Relief	ACETAMINOPHEN	Farmacias De Similares TX LLC	3c477d33-a8c2-d39f-e063-6294a90ac5f0	2025-08-13	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	CHAIN DRUG MARKETING ASSOCIATION INC	4005f8dd-3050-4590-8703-6997444e8df3	2025-08-13	Warnings	Exact identifier application number: M013
good sense headache relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	L. Perrigo Company	4cae0580-7ee3-4f38-8d13-79c7d7615f8f	2025-08-12	Warnings	Exact identifier application number: M013
TYLENOL Extra Strength	ACETAMINOPHEN	Kenvue Brands LLC	3bb7dc60-97b2-1291-e063-6294a90a26d9	2025-08-12	Warnings	Exact identifier application number: M013
Dr Simi Pain Reliever PM	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	Farmacias De Similares TX LLC	3c19ad99-6e0f-3116-e063-6394a90a914c	2025-08-11	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
313782	acetaminophen 325 MG Oral Tablet	PSN	004c39cd-b4f4-1cae-e063-6394a90a0697	5
313782	acetaminophen 325 MG Oral Tablet	SCD	004c39cd-b4f4-1cae-e063-6394a90a0697	5
313782	APAP 325 MG Oral Tablet	SY	004c39cd-b4f4-1cae-e063-6394a90a0697	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68071-3454-3	68071345403	30 TABLET in 1 BOTTLE, PLASTIC (68071-3454-3)	30 tablet	2023-07-12	No	No	Current
68071-3454-4	68071345404	40 TABLET in 1 BOTTLE, PLASTIC (68071-3454-4)	40 tablet	2023-07-12	No	No	Current
68071-3454-5	68071345405	50 TABLET in 1 BOTTLE, PLASTIC (68071-3454-5)	50 tablet	2023-07-12	No	No	Current