Pain Relief Extra Strength

Product NDC: 53345-019
11-digit product format: 533450019
Labeler code: 53345
Product ID: 53345-019_27c7638c-508b-3868-e063-6394a90af73b
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOPHEN
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-01-06
Substance: ACETAMINOPHEN
Active strength: 500 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
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 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
198439	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
5c42dd28-820c-4cc5-9016-11ad5e580616	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53345-019-01	Pain Relief Extra Strength	1 in 1 BOX	CAPSULE, LIQUID FILLED	1	5
53345-019-01	Pain Relief Extra Strength	3000 in 1 BAG	CAPSULE, LIQUID FILLED	3000	5
53345-019-02	Pain Relief Extra Strength	1 in 1 BOX	CAPSULE, LIQUID FILLED	1	5
53345-019-02	Pain Relief Extra Strength	2000 in 1 BAG	CAPSULE, LIQUID FILLED	2000	5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53345-019	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]	5	Current NDC, Legacy NDC, 4 package rows	20241127_5c42dd28-820c-4cc5-9016-11ad5e580616.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 52 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Equaline Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	United Natural Foods, Inc. dba UNFI	739237a5-cc62-8ad6-e053-2991aa0a91f8	2024-12-17	Warnings	Exact identifier application number: M013
NOTTS - Muscle Aches and Pain	ACETAMINOPHEN	VIVUNT PHARMA LLC	e6741300-4573-2580-e053-2a95a90a599c	2024-12-17	Warnings	Exact identifier application number: M013
Extra Strength Pain Reliever, Caseys 4good	ACETAMINOPHEN 500MG, FILM-COATED CAPLET	Lil' Drug Store Products, Inc.	e5fc5340-c224-e02b-e053-2a95a90a5297	2024-12-16	Warnings	Exact identifier application number: M013
Pain Reliever, Caseys 4good	ACETAMINOPHEN 500 MG, TABLET	Lil' Drug Store Products, Inc.	039d2cf1-57f6-4d9d-e063-6394a90a5492	2024-12-16	Warnings	Exact identifier application number: M013
Extra Strength Headache, Caseys 4good	ACETAMINOPHEN, ASPIRIN, CAFFEINE TABLET	Lil' Drug Store Products, Inc.	0425c6a8-a3ea-24ad-e063-6294a90ae15a	2024-12-16	Warnings	Exact identifier application number: M013
Lil Drug Store Childrens Pain and Fever	ACETAMINOPHEN	Lil' Drug Store Products, Inc.	5fcd41ad-449f-4090-be19-eae4171de891	2024-12-16	Warnings	Exact identifier application number: M013
Acetaminophen 250mg Aspirin 250mg Caffeine 65mg	ACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MG	CVS Pharmacy	b9e75551-1e50-9896-e053-2a95a90aafd4	2024-12-14	Warnings	Exact identifier application number: M013
Acetaminophen 250mg Aspirin 250mg Caffeine 65mg	ACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MG	CVS Pharmacy	b9e5df0e-06d3-6f72-e053-2995a90a2d07	2024-12-14	Warnings	Exact identifier application number: M013
Alka-Seltzer Heartburn and Pain	ANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATE	Bayer HealthCare LLC.	2928e140-c868-5bf5-e063-6394a90ab024	2024-12-13	Warnings	Exact identifier application number: M013
foster and thrive pain reliever	ACETAMINOPHEN	Strategic Sourcing Services LLC	b8ee568c-80cf-4e35-865e-35516bdab0fd	2024-12-13	Warnings	Exact identifier application number: M013
Headache Relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Strive Pharmaceuticals Inc.	c0de0bd2-4868-46dc-a20f-3ca02caaa26b	2024-12-11	Warnings	Exact identifier application number: M013
Rite Aid Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Rite Aid	b4797380-9cef-d640-e053-2a95a90a0665	2024-12-11	Warnings	Exact identifier application number: M013
Top Value Effervescent Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICAROBONATE	Tower Laboratories Ltd	44babed8-cf38-1c12-e054-00144ff8d46c	2024-12-11	Warnings, Adverse reactions	Exact identifier application number: M013
Best Choice Effervescent Antacid Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Valu Merchandisers Company	b5e2300a-b77b-53cc-e053-2a95a90a7a6e	2024-12-11	Warnings	Exact identifier application number: M013
EXTRA STRENGTH Headache Relief geltabs	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Strive Pharmaceuticals Inc.	b432771a-4f7d-4d39-a038-d1561d8f6708	2024-12-11	Warnings	Exact identifier application number: M013
Pain Relief Childrens	ACETAMINOPHEN	QUALITY CHOICE (Chain Drug Marketing Association)	223ffb2b-3ee5-4118-955b-bc4fa4e8a2e6	2024-12-10	Warnings	Exact identifier application number: M013
acetaminophen	ACETAMINOPHEN	UNFI	e689c9e3-dd4d-c646-e053-2a95a90a4b6a	2024-12-09	Warnings	Exact identifier application number: M013
DrKids Childrens Pain and Fever	ACETAMINOPHEN 80MG/PIECE	CalmCo LLC	ff4b0528-39a0-80d5-e053-6394a90a8a83	2024-12-07	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	DISCOUNT DRUG MART	972f09a7-2aa1-4b1b-a6dc-2c4578a07803	2024-12-05	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	DISCOUNT DRUG MART	e6feff0a-3347-194d-e053-2a95a90acd20	2024-12-05	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
198439	acetaminophen 500 MG Oral Capsule	PSN	5c42dd28-820c-4cc5-9016-11ad5e580616	5
198439	acetaminophen 500 MG Oral Capsule	SCD	5c42dd28-820c-4cc5-9016-11ad5e580616	5
198439	APAP 500 MG Oral Capsule	SY	5c42dd28-820c-4cc5-9016-11ad5e580616	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53345-019-01	53345001901	1 BAG in 1 BOX (53345-019-01) / 3000 CAPSULE, LIQUID FILLED in 1 BAG	1 bag	2014-01-06	0000-00-00	No	No	Current
53345-019-02	53345001902	1 BAG in 1 BOX (53345-019-02) / 2000 CAPSULE, LIQUID FILLED in 1 BAG	1 bag	2014-01-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pain Relief Extra Strength - Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. \| Epic Pharma, LLC	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. \| Epic Pharma, LLC	2024-11-25	HUMAN OTC DRUG LABEL	5