Pain Relief

Product NDC: 63868-507
11-digit product format: 638680507
Labeler code: 63868
Product ID: 63868-507_243562aa-4855-9d50-e063-6394a90a7cac
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: 2007-08-14
Marketing end: 2026-12-31
Substance: ACETAMINOPHEN
Active strength: 500 mg/1
NDC exclude flag: No
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: Pain Relief
Brand name suffix: Extra Strength

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
5de40821-3218-4320-bf11-9493bf01d489	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63868-507-01	Pain ReliefExtra Strength	1 in 1 CARTON	TABLET, COATED	1		3
63868-507-01	Pain ReliefExtra Strength	100 in 1 BOTTLE, PLASTIC	TABLET, COATED	100		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63868-507-01	EA - Each	63868-507	aeb03cf1-4940-48d3-b7ea-eb54bdfed595	1	2014-11-05

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]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	1
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	1
SODIUM STARCH GLYCOLATE TYPE A CORN	INACTIVE INGREDIENT	AG9B65PV6B	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-507	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	3	Current NDC, Legacy NDC, 2 package rows	20241013_5de40821-3218-4320-bf11-9493bf01d489.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 70 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Handy Solutions Headache Pain Relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Navajo Manufacturing Company Inc.	e5481abe-6971-2bc5-e053-2995a90ae895	2024-04-15	Warnings	Exact identifier application number: M013
childrens acetaminophen	ACETAMINOPHEN	Major Pharmaceuticals	243a5cff-e506-434b-ab19-1a6ac53f8533	2024-04-15	Warnings	Exact identifier application number: M013
Dye Free Pain Reliever Childrens	ACETAMINOPHEN	P & L Development, LLC	45ddcaad-d416-4d7c-a84a-43548d5c5d3b	2024-04-15	Warnings	Exact identifier application number: M013
Tylenol Extra Strength	ACETAMINOPHEN	Navajo Manufacturing Company Inc.	65bf1556-f25a-9439-e053-2a91aa0a3194	2024-04-15	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	Kroger Company	bbeebdd6-fe2c-5b8a-e053-2a95a90ab95e	2024-04-13	Warnings	Exact identifier application number: M013
infants pain relief	ACETAMINOPHEN	Publix Super Markets Inc	3d1818a7-d3b2-434c-b3c9-b2713f08ded2	2024-04-13	Warnings	Exact identifier application number: M013
Mommys Bliss Childrens Pain and Fever	ACETAMINOPHEN	Mom Enterprises, LLC.	08b9eaf7-70d1-640f-e063-6394a90a8d3b	2024-04-12	Warnings	Exact identifier application number: M013
Mommys Bliss Infants Pain and Fever	ACETAMINOPHEN	Mom Enterprises, LLC.	05e26650-81b3-d7b1-e063-6394a90a14ed	2024-04-11	Warnings	Exact identifier application number: M013
Childrens Pain Relief	CHILDRENS PAIN RELIEF	Allegiant Health	7381dd26-c507-4d02-b989-cfd96e02f495	2024-04-11	Warnings	Exact identifier application number: M013
Childrens Pain Relief Dye-Free	ACTEAMINOPHEN	WinCo Foods, LLC	5ee134b3-b8e9-4621-b0a1-a84d9867ccba	2024-04-11	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	WALGREENS	0b1d086f-7be1-5072-e063-6394a90a11e6	2024-04-10	Warnings	Exact identifier application number: M013
Dye Free Infants Pain and Fever	ACETAMINOPHEN	WALGREENS	0b1d88d8-56ff-9e9d-e063-6394a90a015c	2024-04-09	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	H E B	4d572228-3141-4539-9c3d-2fd06e94eee3	2024-04-09	Warnings	Exact identifier application number: M013
Excedrin Extra Strength Pain Reliever	ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE	Haleon US Holdings LLC	1b5ff867-5442-4cf8-bd1e-530093cc88f8	2024-04-05	Warnings	Exact identifier application number: M013
Excedrin Extra Strength Pain Reliever	ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE	Haleon US Holdings LLC	0faa3592-4d56-4645-9a0e-066e0bdfebb6	2024-04-05	Warnings	Exact identifier application number: M013
Pain Relief Childrens Dye Free	ACETAMINOPHEN	H E B	3f9beeeb-5e27-4b81-a647-20e65f0e9fc9	2024-04-03	Warnings	Exact identifier application number: M013
Low Dose Aspirin	ASPIRIN	H E B	edb321dd-e5cb-4031-a8a8-efce9e86fe16	2024-04-03	Warnings	Exact identifier application number: M013
Childrens Pain Relief	ACETAMINOPHEN	H E B	a0c0277e-50aa-4328-8f93-ab20c6176b2b	2024-04-03	Warnings	Exact identifier application number: M013
Regular Strength Enteric coated aspirin	ASPIRIN	Bryant Ranch Prepack	bda805ab-7f37-405d-a144-4e06ad9a29a1	2024-04-03	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Family Dollar (FAMILY WELLNESS)	650cb15e-c448-4df3-b0f8-4398be05d841	2024-03-27	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	5de40821-3218-4320-bf11-9493bf01d489	3
198440	acetaminophen 500 MG Oral Tablet	SCD	5de40821-3218-4320-bf11-9493bf01d489	3
198440	APAP 500 MG Oral Tablet	SY	5de40821-3218-4320-bf11-9493bf01d489	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63868-507-01	63868050701	1 BOTTLE, PLASTIC in 1 CARTON (63868-507-01) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC	2007-08-14	2026-12-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Quality Choice Pain Relief Extra Strength Easy Tabs - 2014-1027	Chain Drug Marketing Association	2024-10-11	HUMAN OTC DRUG LABEL	3