ATAMEL Forte

Product NDC: 69729-800
11-digit product format: 697290800
Labeler code: 69729
Product ID: 69729-800_5ca4c11a-688b-3d5d-e063-6394a90ae677
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, COATED
Route: ORAL
Labeler: OPMX LLC
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2026-01-29
Substance: ACETAMINOPHEN
Active strength: 650 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
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: ATAMEL Forte
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	650 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
75d4bef7-334c-4a95-abb5-bff9def24114	Product name	2	20260112
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7f	Product name	5	20250115
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
88300afc-e1c4-ad17-c80b-4957f1b809a5	Product name	5	20250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043	Product name	7	20240611
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66f	Product name	1	20230808
a3631b20-02d1-41d7-8187-5e5e850b9e80	Product name	1	20230306
79e1734e-f721-4d46-978a-be382f771672	Product name	2	20230110
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6	Product name	9	20220921
92ead9ae-674d-4eee-a492-c385d496891f	Product name	3	20220308
103b151b-b17f-42ac-8624-3ef62f5e2975	Product name	2	20200507
b8497372-efe9-9dde-fa2d-59be9761aa64	Product name	9	20200428
20c8cafe-5cfc-44f8-a9be-a664f437f780	Product name	2	20200225
3a16d77a-e865-468a-aedf-6e58913c1c21	Product name	3	20190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880	Product name	1	20190320
00d531e4-b130-8c52-eaf9-826cbb6f15dd	Product name	3	20190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659	Product name	9	20190205
22d922aa-c443-d9f3-b23c-03b03a9ad31c	Product name	7	20181220
377068df-225f-7318-a910-a1987cdfa361	Product name	3	20170608
23475c0b-a5b5-4fec-b97f-acca901eae6a	Product name	1	20140718
105ef617-6fa4-6713-326f-72ec8a6b75a9	Product name	1	20140508
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
3ed6b849-48b8-8899-c288-6eeb396123b6	Product name	1	20140508
47fd879b-91c5-e1e5-130f-29d082a871ec	Product name	1	20140508
53855190-7124-8179-f018-e792f7c27f28	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0	Product name	1	20140508
96c5169b-5b9d-547d-bf22-d688d91866e4	Product name	1	20140508
b8e0daf1-fb81-290b-c0bf-873be19ef775	Product name	1	20140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00	Product name	1	20140508
c8753a88-edde-8e17-a396-705537b52cee	Product name	1	20140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ce	Product name	1	20140508
cf3a804d-0326-aa22-0142-c184b5657d85	Product name	1	20140508
d83c592c-dd97-4cbf-36ac-13da806684bd	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69729-800-24	ATAMEL Forte	12 in 1 BLISTER PACK	TABLET, COATED	12		1
69729-800-24	ATAMEL Forte	2 in 1 CARTON	TABLET, COATED	2		1

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 47 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GOOD REMEDIES Extra Strength Pain Relief PM Caplet	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	2d642d8e-c154-a970-e063-6294a90a03bf	2025-03-14	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	DISCOUNT DRUG MART	97f78c4a-9d0d-4fe1-8b2b-d5f8ab939ac4	2025-03-07	Warnings	Exact identifier application number: M013
Redicare Non-Aspirin 500mg	REDICARE NON-ASPIRIN, ACETAMINOPHEN 500MG	Redicare LLC	2f229898-1777-732c-e063-6394a90a76bc	2025-03-04	Warnings, Adverse reactions	Exact identifier application number: M013
Major Extra Strength Acetaminophen Liquid	ACETAMINOPHEN	Major Pharmaceuticals	2f3af4dd-45d5-87b4-e063-6294a90ab3cc	2025-02-28	Warnings	Exact identifier application number: M013
LOW DOSE ASPIRIN	ASPIRIN	NCS HealthCare of KY, LLC dba Vangard Labs	ed9a71d6-a56e-416a-bb89-6d41307efc5a	2025-02-27	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	PD-Rx Pharmaceuticals, Inc.	77429b7f-78e4-42c0-8679-ae8da1748848	2025-02-26	Warnings	Exact identifier application number: M013
AeroTab Non-Aspirin	ACETAMINOPHEN 500MG ES	Aero Healthcare	faa3a4ef-3c70-06ca-e053-6394a90a512d	2025-02-26	Warnings	Exact identifier application number: M013
Bufferin Regular Strength Pain Relief	ASPIRIN	Genomma Lab USA	3543b2bf-1062-468a-a5dc-eabb2408af8c	2025-02-25	Warnings	Exact identifier application number: M013
Calmour Childrens Acetaminophen Strips Chewable	ACETAMINOPHEN ORAL CHEWABLE 80 MG	Calmour	ae47b027-4f29-45bb-a8bd-812978932835	2025-02-22	Warnings	Exact identifier application number: M013
Infants TYLENOL	ACETAMINOPHEN	Kenvue Brands LLC	f9de7c2f-016b-4f40-8b5e-141ad194be97	2025-02-20	Warnings	Exact identifier application number: M013
Genexa Acetaminophen PM Extra Strength	ACETAMINOPHEN	Genexa Inc.	d82cf6f3-a291-ca2b-e053-2a95a90a6de1	2025-02-20	Warnings	Exact identifier application number: M013
Childrens Acetaminophen	ACETAMINOPHEN	Advagen Pharma Limited	8b9456c9-a56b-4748-adb8-c66d6bf072e8	2025-02-19	Warnings	Exact identifier application number: M013
Genexa Childrens Acetaminophen	ACETAMINOPHEN	Genexa Inc.	d89fd9d8-d88e-3968-e053-2a95a90afc5f	2025-02-19	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Precision Dose, Inc.	debfa787-7a48-48b5-94b0-612820524032	2025-02-19	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Precision Dose, Inc.	b16e5dcf-b290-4ff2-a150-4b875647ec9a	2025-02-19	Warnings	Exact identifier application number: M013
TYLENOL Extra Strength	ACETAMINOPHEN	Kenvue Brands LLC	bb6533e5-e6a9-488c-b8ab-a6a06e87ede9	2025-02-18	Warnings	Exact identifier application number: M013
TYLENOL Extra Strength	ACETAMINOPHEN	Kenvue Brands LLC	c830320e-72ba-48ff-a4cd-250ac5650bf0	2025-02-18	Warnings	Exact identifier application number: M013
Aspirina Caplets	ASPIRIN	Bayer HealthCare LLC.	2e6f5ba8-8e8b-6059-e063-6394a90adcd5	2025-02-18	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	PD-Rx Pharmaceuticals, Inc.	da7d95af-6583-429d-8d04-e0424f32e9ad	2025-02-17	Warnings	Exact identifier application number: M013
GOODYS Mental Alert	ASPIRIN AND CAFFEINE	Medtech Products Inc.	31ef6d07-d314-4d09-abcd-389ba66cbcc5	2025-02-17	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
198444	acetaminophen 650 MG Oral Tablet	PSN	4988c97a-af39-16a8-e063-6294a90a8993	1
198444	acetaminophen 650 MG Oral Tablet	SCD	4988c97a-af39-16a8-e063-6294a90a8993	1
198444	APAP 650 MG Oral Tablet	SY	4988c97a-af39-16a8-e063-6294a90a8993	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
69729-800-24	69729080024	2 BLISTER PACK in 1 CARTON (69729-800-24) / 12 TABLET, COATED in 1 BLISTER PACK	2 blister pack	2026-01-29	No	No	Current