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 55 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ACETAMINOPHEN (RED)	ACETAMINOPHEN	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd	a352f588-4a70-42b2-8f9c-a73a0629517d	2024-11-25	Warnings	Exact identifier application number: M013
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

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