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 55 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Relief Extra Strength	ACETAMINOPHEN	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	5c42dd28-820c-4cc5-9016-11ad5e580616	2024-11-25	Warnings	Exact identifier application number: M013
equate pain reliever	ACETAMINOPHEN	WALMART INC.	4518fe82-3ba8-4e9e-a036-776df7fb8d57	2024-11-21	Warnings	Exact identifier application number: M013
Family Wellness Pain Reliever	ASPIRIN	FAMILY WELLNESS SERVICES, INC.	075e19f4-1a58-aedd-e063-6294a90af708	2024-11-20	Warnings	Exact identifier application number: M013
Mejoralito	ACETAMINOPHEN	OPMX Chula Vista	fd2ecde0-296e-060f-e053-6294a90afd98	2024-11-15	Warnings	Exact identifier application number: M013
Temp X	ACETAMINOPHEN	OPMX Chula Vista	fd2edc32-0351-c991-e053-6294a90ab4ce	2024-11-15	Warnings	Exact identifier application number: M013
CVS Health Extra Strength Antacid and Pain Reliever	ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE	CVS Pharmacy	afe9e755-18ba-305f-e053-2995a90aa8d0	2024-11-14	Warnings	Exact identifier application number: M013
Walgreens Effervescent Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Walgreens	667418fc-a3ab-cbc7-e053-2a91aa0a2023	2024-11-13	Warnings	Exact identifier application number: M013
Up and Up Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Target Corporation	a72eef45-b985-638a-e053-2995a90aa20a	2024-11-13	Warnings	Exact identifier application number: M013
Signature Care Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Safeway, Inc	6e120024-475a-73af-e053-2a91aa0a42a6	2024-11-13	Warnings, Adverse reactions	Exact identifier application number: M013
Kroger Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Kroger Company	6d858b0e-a3c8-2686-e053-2991aa0acc06	2024-11-13	Warnings	Exact identifier application number: M013
TopCare Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Topco Associates LLC	639f9d57-f26a-708a-e053-2a91aa0a6962	2024-11-13	Warnings, Adverse reactions	Exact identifier application number: M013
Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	H. E. Butt Grocery Company	6418cde9-607b-4ca1-e053-2991aa0a9170	2024-11-13	Warnings	Exact identifier application number: M013
Bromo Seltzer	ASPIRIN, SODIUM BICARBONATE, CITRIC ACID	Tower Laboratories Ltd	8ff88ee1-e33e-4051-992f-24e2720c48ce	2024-11-13	Warnings	Exact identifier application number: M013
Care One Original Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Foodhold U.S.A.	8f662c51-d2fa-6458-e053-2995a90ac6fd	2024-11-13	Warnings	Exact identifier application number: M013
Top Value Effervescent Pain Relief	APIRIN, CITRIC ACID, SODIUM BICARBONATE	Tower Laboratories Ltd	43c7f435-735c-3fab-e054-00144ff88e88	2024-11-13	Warnings, Adverse reactions	Exact identifier application number: M013
DG Health Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	DOLGENCORP, INC	8f1343d5-2884-3a14-e053-2a95a90a2f90	2024-11-13	Warnings	Exact identifier application number: M013
Good Sense Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Good Sense	cd25b0c3-0134-beef-e053-2a95a90a092b	2024-11-13	Warnings	Exact identifier application number: M013
Drug Mart Effervescent Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Discount Drug Mart, Inc	8bc65603-1dbf-30ab-e053-2995a90a7c15	2024-11-13	Warnings	Exact identifier application number: M013
Best Choice Effervescent Antacid Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Valu Merchandisers Company	8aab905b-5fe7-dddb-e053-2995a90a6c6f	2024-11-13	Warnings	Exact identifier application number: M013
Publix Fast Relief Effervescent	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Publix Super Markets Inc.	73051f16-2569-7394-e053-2991aa0a5359	2024-11-13	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	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