Pain Relief

Product NDC: 63868-084
11-digit product format: 638680084
Labeler code: 63868
Product ID: 63868-084_243531d9-3c42-d20a-e063-6294a90a2b09
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Chain Drug Marketing Association
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-06-13
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	63868-084	63868-084-10	D	Discontinued by firm	2026-10-21
excluded package	package	63868-084	63868-084-20	D	Discontinued by firm	2026-10-21
excluded package	package	63868-084	63868-084-24	D	Discontinued by firm	2026-10-21
excluded package	package	63868-084	63868-084-50	D	Discontinued by firm	2026-10-21

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`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
68a52858-35c5-402a-8ceb-8d8a7c1e5f6c	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63868-084-05	Pain ReliefExtra Strength	500 in 1 BOTTLE, PLASTIC	TABLET, COATED	500	5
63868-084-10	Pain ReliefExtra Strength	100 in 1 BOTTLE, PLASTIC	TABLET, COATED	100	5
63868-084-10	Pain ReliefExtra Strength	1 in 1 CARTON	TABLET, COATED	1	5
63868-084-20	Pain ReliefExtra Strength	100 in 1 BOTTLE, PLASTIC	TABLET, COATED	100	5
63868-084-20	Pain ReliefExtra Strength	2 in 1 CARTON	TABLET, COATED	2	5
63868-084-24	Pain ReliefExtra Strength	24 in 1 BOTTLE, PLASTIC	TABLET, COATED	24	5
63868-084-24	Pain ReliefExtra Strength	1 in 1 CARTON	TABLET, COATED	1	5
63868-084-50	Pain ReliefExtra Strength	1 in 1 CARTON	TABLET, COATED	1	5
63868-084-50	Pain ReliefExtra Strength	50 in 1 BOTTLE, PLASTIC	TABLET, COATED	50	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63868-084-05	EA - Each	63868-084	047c6c6e-26bd-41bb-8750-06ef044c203e	1	2019-08-06
63868-084-10	EA - Each	63868-084	99f880e3-f152-4275-b7f0-3d3c194853a4	1	2020-03-10
63868-084-24	EA - Each	63868-084	cfc2bdbf-80de-46fe-a6cf-f67889886cc2	1	2020-04-20
63868-084-50	EA - Each	63868-084	1714a893-18f4-4100-a4c5-afff5894cacf	1	2018-07-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	2
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	2
SODIUM STARCH GLYCOLATE TYPE A CORN	INACTIVE INGREDIENT	AG9B65PV6B	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-084	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	5	Current NDC, Legacy NDC, 9 package rows	20241013_68a52858-35c5-402a-8ceb-8d8a7c1e5f6c.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 74 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LOW DOSE ASPIRIN	ASPIRIN	Bryant Ranch Prepack	64c28b38-23bb-4c7e-9c19-1d1f0d597528	2024-01-18	Warnings	Exact identifier application number: M013
Buscapina	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	OPMX LLC	e0dd4c04-6811-38a1-e053-2995a90aa3c9	2024-01-17	Warnings	Exact identifier application number: M013
Regular Strength Acetaminophen	ACETAMINOPHEN	CARDINAL HEALTH	bdf8c511-ce25-0e30-e053-2a95a90a33f6	2024-01-10	Warnings	Exact identifier application number: M013
Extra Strength Acetaminophen PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	KROGER COMPANY	2560126e-a54a-4a47-9631-a1bca42f5277	2024-01-10	Warnings	Exact identifier application number: M013
LOW DOSE ASPIRIN	ASPIRIN	A-S Medication Solutions	ee4451c9-4d0f-4373-8f64-fcc1f9dd5856	2024-01-05	Warnings	Exact identifier application number: M013
Pharbetol	ACETAMINOPHEN	Proficient Rx LP	51ba690e-d76b-41c6-a083-8bc803e1faa2	2024-01-01	Warnings	Exact identifier application number: M013
MEDI-FIRST Non-Aspirin Extra Strength	ACETAMINOPHEN	Proficient Rx LP	9071b047-5463-4f65-b775-bfb0ce066527	2024-01-01	Warnings	Exact identifier application number: M013
LOW DOSE ASPIRIN	ASPIRIN	TIME CAP LABORATORIES, INC	1acc8c1a-c746-4635-800c-de1ad758fce0	2023-12-30	Warnings	Exact identifier application number: M013
MAX Cold, Flu, and Sore Throat	ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN , PHENYLEPHRINE HCL	H E B	9b09b660-0758-48dc-84c9-26cdd2aacc03	2023-12-29	Warnings	Exact identifier application number: M013
NIGHT-TIME MULTI-SYMPTOM COLD/FLU Original	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	DeMoulas Market Basket	eb24323f-82a1-4ba3-9359-fe81571c3fba	2023-12-29	Warnings	Exact identifier application number: M013
Nite-TimeCOLD/FLU CHERRY COLD/FLU CHERRY	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Salado Sales, Inc.	e6c3e545-b2ad-47f0-8318-c134a8e24f5b	2023-12-29	Warnings	Exact identifier application number: M013
Daytime Non-Drowsy COLD/FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Salado Sales, Inc.	e181b371-78c7-4163-865d-acc064be33ca	2023-12-29	Warnings	Exact identifier application number: M013
Childrens Pain and Fever Cherry flavor	ACETAMINOPHEN	Walgreen Company	64c65244-f7a3-401b-b83a-bf66d45268e2	2023-12-29	Warnings	Exact identifier application number: M013
Nite-Time COLD/FLU ORIGINAL	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Salado Sales, Inc.	fcd24753-b42b-4d05-8379-0ec0351ab217	2023-12-29	Warnings	Exact identifier application number: M013
NIGHT-TIME MULTI-SYMPTOM COLD/FLU Cherry	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	DeMoulas Market Basket	e772cdf5-d01d-4752-8cfb-7e7f4d7a8dd0	2023-12-29	Warnings	Exact identifier application number: M013
Childrens Pain and Fever, Grape flavor	ACETAMINOPHEN	Walgreen Company	0995d69f-61aa-40b0-b095-bb8595caf773	2023-12-29	Warnings	Exact identifier application number: M013
DAY-TIME Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	DeMoulas Market Basket	ce900e42-d0c8-408d-a1c3-3a9bef1c97ee	2023-12-29	Warnings	Exact identifier application number: M013
Pain Relief PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	DOLGENCORP, INC.	06553550-5685-f3c3-e063-6394a90aef07	2023-12-22	Warnings	Exact identifier application number: M013
Tension Headache Pain Relieving Aid	ACETAMINOPHEN,CAFFEINE	WAL-MART STORES INC	00fadd26-a6eb-dc5e-e063-6394a90a3cca	2023-12-15	Warnings	Exact identifier application number: M013
Dye-Free Aspirin 81	ASPIRIN	WALGREENS	d71a9d3a-cd28-14a8-e053-2995a90a832b	2023-12-15	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	68a52858-35c5-402a-8ceb-8d8a7c1e5f6c	5
198440	acetaminophen 500 MG Oral Tablet	SCD	68a52858-35c5-402a-8ceb-8d8a7c1e5f6c	5
198440	APAP 500 MG Oral Tablet	SY	68a52858-35c5-402a-8ceb-8d8a7c1e5f6c	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63868-084-05	63868008405	500 TABLET, COATED in 1 BOTTLE, PLASTIC (63868-084-05)	2014-06-13	0000-00-00	No	No	Current
63868-084-10	63868008410	1 BOTTLE, PLASTIC in 1 CARTON (63868-084-10) > 100 TABLET, COATED in 1 BOTTLE, PLASTIC	2014-06-13	0000-00-00	No	No	Current
63868-084-20	63868008420	100 in 1 BOTTLE, PLASTIC					Historical
63868-084-24	63868008424	1 BOTTLE, PLASTIC in 1 CARTON (63868-084-24) > 24 TABLET, COATED in 1 BOTTLE, PLASTIC	2014-06-13	0000-00-00	No	No	Current
63868-084-50	63868008450	1 BOTTLE, PLASTIC in 1 CARTON (63868-084-50) > 50 TABLET, COATED in 1 BOTTLE, PLASTIC	2014-06-13	0000-00-00	No	No	Current