Pain Relief

Product NDC: 36800-770
11-digit product format: 368000770
Labeler code: 36800
Product ID: 36800-770_286014c1-2183-fc25-e063-6394a90aa15e
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, COATED
Route: ORAL
Labeler: TopCo Associates LLC
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-03-31
Substance: ACETAMINOPHEN
Active strength: 500 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	36800-770	36800-770-01	D	Discontinued by firm	2026-10-16
excluded package	package	36800-770	36800-770-03	D	Discontinued by firm	2026-10-16
excluded package	package	36800-770	36800-770-05	D	Discontinued by firm	2026-10-16
excluded package	package	36800-770	36800-770-12	D	Discontinued by firm	2026-10-16

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 · 48 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	36800-770-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	36800-770-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	36800-770-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	36800-770-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	36800-770-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	36800-770-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	36800-770-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	36800-770-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	36800-770-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	36800-770-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	36800-770-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	36800-770-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	36800-770-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	36800-770-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	36800-770-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	36800-770-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	36800-770-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	36800-770-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	36800-770-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	36800-770-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	36800-770-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	36800-770-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	36800-770-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	36800-770-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	36800-770-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	36800-770-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	36800-770-12	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	36800-770-05	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	36800-770-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	36800-770-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	36800-770-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	36800-770-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	36800-770-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	36800-770-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	36800-770-12	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	36800-770-05	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	36800-770-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	36800-770-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	36800-770-12	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	36800-770-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	36800-770-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	36800-770-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	36800-770-12	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	36800-770-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	36800-770-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	36800-770-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	36800-770-12	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	36800-770-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: Pain Relief
Brand name suffix: Extra Strength
Listing expiration: 2026-12-31

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
ecd6df7e-e7e2-446b-85ef-25971281fe31	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
36800-770-01	Pain ReliefExtra Strength	1 in 1 CARTON	TABLET, COATED	1	7
36800-770-01	Pain ReliefExtra Strength	24 in 1 BOTTLE, PLASTIC	TABLET, COATED	24	7
36800-770-02	Pain ReliefExtra Strength	1 in 1 CARTON	TABLET, COATED	1	7
36800-770-02	Pain ReliefExtra Strength	50 in 1 BOTTLE, PLASTIC	TABLET, COATED	50	7
36800-770-03	Pain ReliefExtra Strength	100 in 1 BOTTLE, PLASTIC	TABLET, COATED	100	7
36800-770-03	Pain ReliefExtra Strength	1 in 1 CARTON	TABLET, COATED	1	7
36800-770-05	Pain ReliefExtra Strength	1 in 1 CARTON	TABLET, COATED	1	7
36800-770-05	Pain ReliefExtra Strength	225 in 1 BOTTLE, PLASTIC	TABLET, COATED	225	7
36800-770-12	Pain ReliefExtra Strength	400 in 1 BOTTLE, PLASTIC	TABLET, COATED	400	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-770	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [TOPCO ASSOCIATES LLC]	7	Current NDC, Legacy NDC, 9 package rows	20241206_ecd6df7e-e7e2-446b-85ef-25971281fe31.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 45 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Relief	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION, INC.	1c083e29-8732-4ecd-ab4b-9038acbd0b9d	2025-05-22	Warnings	Exact identifier application number: M013
TYLENOL For Children Plus Adults	ACETAMINOPHEN	Kenvue Brands LLC	5bb8ef99-a94b-49f9-89f9-cd1ce0a47a42	2025-05-21	Warnings	Exact identifier application number: M013
Children Acetaminophen	ACETAMINOPHEN	AARNA USA INC.	25bcb9d5-f388-4ae7-8037-970ffe8d17f0	2025-05-16	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	HF Acquisition Co LLC, DBA HealthFirst	35478de8-50d0-5d0a-e063-6294a90a88ba	2025-05-16	Warnings	Exact identifier application number: M013
Extra Strength Acetaminophen	ACETAMINOPHEN	Preferred Pharmaceuticals Inc.	95f4b628-6d35-4f6b-91f9-b2d117f8e821	2025-05-16	Warnings	Exact identifier application number: M013
good neighbor pharmacy childrens pain and fever	ACETAMINOPHEN	Amerisource Bergen	268a789b-8f31-4739-9777-523249cac326	2025-05-13	Warnings	Exact identifier application number: M013
ASPIRIN LOW DOSE	ASPIRIN LOW DOSE	AARNA USA INC.	347edc8f-6391-b75e-e063-6394a90a1cf5	2025-05-06	Warnings	Exact identifier application number: M013
Good Neighbor Pharmacy Infants Pain and Fever	ACETAMINOPHEN	Amerisource Bergen	2cfbb8ad-3ecb-432b-9eb4-16c51bf23bb2	2025-05-06	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	AARNA USA INC.	34157f6a-3031-4388-e063-6394a90a670f	2025-05-01	Warnings	Exact identifier application number: M013
ASPIRIN	ASPIRIN	HF Acquisition Co LLC, DBA HealthFirst	2553d0cb-3f5c-7ea0-e063-6294a90a3cd4	2025-05-01	Warnings, Adverse reactions	Exact identifier application number: M013
Aspirin 81mg Enteric Coated	ASPIRIN	Advanced Rx LLC	606067bb-b07f-444e-9465-d1e187735f3a	2025-05-01	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	AARNA USA INC.	33f0e822-28af-9bb2-e063-6294a90a5175	2025-04-29	Warnings	Exact identifier application number: M013
Extra Strength Acetaminophen	ACETAMINOPHEN	Geri-Care Pharmaceutical Corp	27fcca07-f845-77fe-e063-6394a90aa2f8	2025-04-24	Warnings	Exact identifier application number: M013
acetaminophen	ACETAMINOPHEN	A-S Medication Solutions	46a6bbb9-ccd1-47a8-9e58-485f71f57063	2025-04-24	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	A-S Medication Solutions	061c91d5-5aa8-4556-a344-197b7e8a10b8	2025-04-24	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	A-S Medication Solutions	c4f0f591-8501-4c6d-bf8e-ca3068ff65b5	2025-04-24	Warnings	Exact identifier application number: M013
Extra Strength No-Pain	ACETAMINOPHEN	Safrel Pharmaceuticals, LLC.	873f01dd-0701-5fd3-e053-2a95a90a6463	2025-04-23	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	Chain Drug Consortium	60d4b392-6ed0-4115-8154-24eaf72504a5	2025-04-16	Warnings	Exact identifier application number: M013
Premsyn pms Premenstrual Pain Relief	ACETAMINOPHEN AND PAMABROM AND PYRILAMINE MALEATE	Focus Consumer Healthcare, LLC	5b6f6260-69ae-cfeb-e053-2a91aa0a6b49	2025-04-14	Warnings	Exact identifier application number: M013
BackAid Max	ACETAMINOPHEN, PAMABROM	Kobayashi Healthcare International, Inc.	fb9a5647-b7c9-4820-b148-91060e34cb83	2025-04-14	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	ecd6df7e-e7e2-446b-85ef-25971281fe31	7
198440	acetaminophen 500 MG Oral Tablet	SCD	ecd6df7e-e7e2-446b-85ef-25971281fe31	7
198440	APAP 500 MG Oral Tablet	SY	ecd6df7e-e7e2-446b-85ef-25971281fe31	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-770-01	36800077001	1 BOTTLE, PLASTIC in 1 CARTON (36800-770-01) > 24 TABLET, COATED in 1 BOTTLE, PLASTIC	2014-03-31	0000-00-00	No	No	Current
36800-770-02	36800077002	1 BOTTLE, PLASTIC in 1 CARTON (36800-770-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC	2014-03-31	0000-00-00	No	No	Current
36800-770-03	36800077003	1 BOTTLE, PLASTIC in 1 CARTON (36800-770-03) > 100 TABLET, COATED in 1 BOTTLE, PLASTIC	2014-03-31	0000-00-00	No	No	Current
36800-770-05	36800077005	1 BOTTLE, PLASTIC in 1 CARTON (36800-770-05) > 225 TABLET, COATED in 1 BOTTLE, PLASTIC	2014-03-31	2022-09-30	No	No	Current
36800-770-12	36800077012	400 TABLET, COATED in 1 BOTTLE, PLASTIC (36800-770-12)	2016-01-01	2022-03-31	No	No	Current