ACETAMINOPHEN

Product NDC: 49483-341
11-digit product format: 494830341
Labeler code: 49483
Product ID: 49483-341_3861fde3-66fe-f10c-e063-6394a90addc0
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOPHEN
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: TIME CAP LABS INC
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2011-07-18
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: ACETAMINOPHEN
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
fd24d0e0-4f36-42d3-9149-2fb957690305	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49483-341-01	ACETAMINOPHENExtra Strength	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	9
49483-341-10	ACETAMINOPHENExtra Strength	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	9
49483-341-20	ACETAMINOPHENExtra Strength	200 in 1 BOTTLE	TABLET, FILM COATED	200	9
49483-341-50	ACETAMINOPHENExtra Strength	500 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	500	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49483-341-01	EA - Each	49483-341	235679f0-0eaa-47b9-899d-635267686003	1	2016-12-07
49483-341-10	EA - Each	49483-341	71d67bca-8711-4a54-a736-537e8c9e887e	1	2022-02-07
49483-341-50	EA - Each	49483-341	2a7fd6e7-9368-4aee-9196-b0ae222c383f	1	2021-06-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [TIME CAP LABS INC]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [TIME CAP LABS INC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ACETAMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [TIME CAP LABS INC]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	ACETAMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [TIME CAP LABS INC]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	ACETAMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [TIME CAP LABS INC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ACETAMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [TIME CAP LABS INC]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ACETAMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [TIME CAP LABS INC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ACETAMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [TIME CAP LABS INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49483-341	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [TIME CAP LABS INC]	8	Current NDC, Legacy NDC, 4 package rows	20231027_fd24d0e0-4f36-42d3-9149-2fb957690305.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 67 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Relief Extra Strength	ACETAMINOPHEN	Chain Drug Marketing Association	cfaf9495-e654-4dfc-ba23-d2358c3720c4	2024-06-13	Warnings	Exact identifier application number: M013
Aspirin 81 mg Low Dose	ASPIRIN	CHAIN DRUG MARKETING ASSOCIATION, INC.	18ff2df8-ee65-4219-ad93-cf5090bfac2d	2024-06-13	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION, INC.	9fdbaf5e-f88b-4d18-97df-0b2e8dddf377	2024-06-13	Warnings	Exact identifier application number: M013
Aspirin 81 mg Low dose	ASPIRIN	CHAIN DRUG MARKETING ASSOCIATION, INC.	bfb9af64-3195-44bf-bcf3-6b36b40d3cc7	2024-06-13	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION, INC.	1ac7ed71-5afe-d09c-e063-6294a90a3b88	2024-06-13	Warnings	Exact identifier application number: M013
Pain Relief PM Extra Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	3ce5bbf2-d449-464e-abeb-5c26866d1ab5	2024-06-13	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	AAA Pharmaceutical, Inc.	609948d6-0f20-4d0c-adc0-6ae72a4f2b7a	2024-06-13	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	AAA Pharmaceutical, Inc.	3f73a359-59d7-47bb-872e-914b0db719af	2024-06-13	Warnings	Exact identifier application number: M013
topcare infants pain and fever	ACETAMINOPHEN	Topco Associates LLC	f1e940ef-3cf0-4a5c-8158-156d0e5a680d	2024-06-13	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Trifecta Pharmaceuticals USA LLC	026bf664-d598-73de-e063-6394a90a9206	2024-06-12	Warnings	Exact identifier application number: M013
Regular Strength Pain Relief	ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	7c73fc75-af9b-177c-e053-2a91aa0ada56	2024-06-12	Warnings	Exact identifier application number: M013
Low Dose Aspirin	ASPIRIN	Topco Associates	4a6a1dbb-c813-42fd-9bb8-497aec339466	2024-06-11	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	The Kroger Co.	fa234639-caf8-4c52-9ffe-f1c0c057ee5b	2024-06-10	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	The Kroger Co.	bc18590d-6481-4efe-8a3b-974f7543b754	2024-06-10	Warnings	Exact identifier application number: M013
ASPIRIN	ASPIRIN	H-E-B	085b35db-62e4-38db-e063-6394a90a9763	2024-06-07	Warnings	Exact identifier application number: M013
pain and fever	ACETAMINOPHEN	Meijer Distribution Inc	cbfa2a25-f1e7-491e-9b67-ff2f4ba0b6cf	2024-06-07	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	The Kroger Co.	5691ac45-5732-412e-abb8-2bfaac59160e	2024-06-07	Warnings	Exact identifier application number: M013
Cafiaspirina Rapid Headache Relief	ASPIRIN, CAFFEINE	Belmora LLC	d890acec-6528-4fb7-8d59-6c572a3f0786	2024-06-07	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	TARGET Corporation	611bc1ce-460a-44a3-8e2d-b28a399d9a44	2024-06-06	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	Meijer Distribution Inc	033a6153-2651-4703-8a94-def461838113	2024-06-05	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
198440	acetaminophen 500 MG Oral Tablet	PSN	fd24d0e0-4f36-42d3-9149-2fb957690305	9
198440	acetaminophen 500 MG Oral Tablet	SCD	fd24d0e0-4f36-42d3-9149-2fb957690305	9
198440	APAP 500 MG Oral Tablet	SY	fd24d0e0-4f36-42d3-9149-2fb957690305	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
49483-341-01	49483034101	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-341-01)	2018-12-17	0000-00-00	No	No	Current
49483-341-10	49483034110	1000 TABLET, FILM COATED in 1 BOTTLE (49483-341-10)	2022-01-20	0000-00-00	No	No	Current
49483-341-20	49483034120	200 TABLET, FILM COATED in 1 BOTTLE (49483-341-20)	2023-10-25		No	No	Current
49483-341-50	49483034150	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-341-50)	2021-05-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
341R TCL 49483 341 Extra Strength Acetaminophen 500 mg	TIME CAP LABS INC \| MARKSANS PHARMA LIMITED	2025-06-25	HUMAN OTC DRUG LABEL	9
Acetaminophen Caplets 8409	NCS HealthCare of KY, LLC dba Vangard Labs	2024-08-13	HUMAN OTC DRUG LABEL	14