Pain Relief

Product NDC: 83324-078
11-digit product format: 833240078
Labeler code: 83324
Product ID: 83324-078_458b4f7d-8f0c-2559-e063-6294a90a663b
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, COATED
Route: ORAL
Labeler: CHAIN DRUG MARKETING ASSOCIATION, INC.
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-04-03
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
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
c57c10fc-f182-4153-8974-ef359a5f5ac1	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
83324-078-01	Pain ReliefExtra Strength	1 in 1 CARTON	TABLET, COATED	1	3
83324-078-01	Pain ReliefExtra Strength	100 in 1 BOTTLE, PLASTIC	TABLET, COATED	100	3
83324-078-05	Pain ReliefExtra Strength	500 in 1 BOTTLE, PLASTIC	TABLET, COATED	500	3
83324-078-15	Pain ReliefExtra Strength	150 in 1 BOTTLE, PLASTIC	TABLET, COATED	150	3
83324-078-24	Pain ReliefExtra Strength	1 in 1 CARTON	TABLET, COATED	1	3
83324-078-24	Pain ReliefExtra Strength	24 in 1 BOTTLE, PLASTIC	TABLET, COATED	24	3
83324-078-50	Pain ReliefExtra Strength	1 in 1 CARTON	TABLET, COATED	1	3
83324-078-50	Pain ReliefExtra Strength	50 in 1 BOTTLE, PLASTIC	TABLET, COATED	50	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
83324-078-01	EA - Each	83324-078	8ba5a904-64d3-4327-93d3-7e433d1e33c2	1	2026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83324-078	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION, INC.]	2	Current NDC, 8 package rows	20240615_c57c10fc-f182-4153-8974-ef359a5f5ac1.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 · 1,576 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Lil Drug Store Aspirin 325	ASPIRIN	Lil Drug Store Products, Inc	de59aae2-f794-4243-acc8-37a10e27abde	2023-12-15	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN TABLET, EXTRA STRENGTH	Lil' Drug Store Products, Inc.	f0fdab5a-9d07-57aa-e053-2a95a90adc7f	2023-12-15	Warnings	Exact identifier application number: M013
BC Cherry	ASPIRIN AND CAFFEINE	Lil' Drug Store Products, Inc	79ea721b-d656-44f7-9d13-390debee7be0	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	c57c10fc-f182-4153-8974-ef359a5f5ac1	3
198440	acetaminophen 500 MG Oral Tablet	SCD	c57c10fc-f182-4153-8974-ef359a5f5ac1	3
198440	APAP 500 MG Oral Tablet	SY	c57c10fc-f182-4153-8974-ef359a5f5ac1	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
83324-078-01	83324007801	1 BOTTLE, PLASTIC in 1 CARTON (83324-078-01) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC	2024-04-03	No	No	Current
83324-078-05	83324007805	500 TABLET, COATED in 1 BOTTLE, PLASTIC (83324-078-05)	2024-04-03	No	No	Current
83324-078-15	83324007815	150 TABLET, COATED in 1 BOTTLE, PLASTIC (83324-078-15)	2024-04-03	No	No	Current
83324-078-24	83324007824	1 BOTTLE, PLASTIC in 1 CARTON (83324-078-24) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC	2024-04-03	No	No	Current
83324-078-50	83324007850	1 BOTTLE, PLASTIC in 1 CARTON (83324-078-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC	2024-04-03	No	No	Current