FDA.reportPublic FDA data

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
IngredientStrength
ACETAMINOPHEN650 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
377068df-225f-7318-a910-a1987cdfa361Product name320170608
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69729-800-24ATAMEL Forte12 in 1 BLISTER PACKTABLET, COATED121
69729-800-24ATAMEL Forte2 in 1 CARTONTABLET, COATED21

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 26 of 83 · 1,657 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gemma Cut the CrampASPIRIN, CAFFEINERally Labs LLC16c9a296-077a-8e12-e063-6294a90a1b8b2025-12-29WarningsExact identifier
application number: M013
BlowfishASPIRIN, CAFFEINERally Labs LLC0d3798bc-04ef-584e-821b-7aa76036b7d12025-12-29WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINEPioneer Life Sciences, LLCad29a37f-39a2-5c84-e053-2995a90a2f392025-12-29WarningsExact identifier
application number: M013
Tension Headache ReliefACETAMINOPHEN, CAFFEINEPioneer Life Sciences, LLCac9efd62-8fee-b777-e053-2995a90a37832025-12-29WarningsExact identifier
application number: M013
Childrens Pain Relief and Fever Reducer Oral Suspension CherryACETAMINOPHENPuro Pharma Inc.a2afaee7-19f3-4a42-a5b8-1d0ef3ecf0092025-12-27WarningsExact identifier
application number: M013
Cystex PMACETAMINOPHEN, DIPHENHYDRAMINE HCLClarion Brands, LLC9668a2ca-729e-4172-80b5-33e6c5175ba42025-12-27WarningsExact identifier
application number: M013
Excedrin Extra Strength HeadacheACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINESelect Consumer Group3caa0a47-de83-90d2-e063-6394a90a34362025-12-27WarningsExact identifier
application number: M013
Aspirin Pain reliverASPIRINPioneer Life Sciences, LLCc2759844-a49c-450f-e053-2a95a90a29722025-12-26WarningsExact identifier
application number: M013
Menstrual CompleteACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEPioneer Life Sciences, LLCaa2de3a5-a20d-33c6-e053-2a95a90ada3e2025-12-26WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENDiscount Drug Mart2aa0f9f3-924c-4a4a-bb5f-2a326acc24082025-12-26WarningsExact identifier
application number: M013
GenCare Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEPioneer Life Sciences, LLC667f6f1b-5179-481c-a131-940c7937aada2025-12-26WarningsExact identifier
application number: M013
PharbetolACETAMINOPHENPharbest Pharmaceuticals, Inc.04dbd98f-c74d-43b2-8bda-74f18be7cf6c2025-12-24WarningsExact identifier
application number: M013
Adult Low Dose Aspirin Enteric CoatedASPIRIN 81MGPharbest Pharmaceuticals, Inc.45e5bae9-22a7-4699-85ea-5b922af6b96d2025-12-24WarningsExact identifier
application number: M013
Aspirin 325 mgASPIRINBETTER LIVING BRANDS, LLC424a242f-c8c6-9dd7-e063-6394a90ab4d52025-12-24WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINPharbest Pharmaceuticals, Inc.2763a733-d617-4d95-8429-fbf81d9d77fb2025-12-24WarningsExact identifier
application number: M013
Pharbetol Regular strengthACETAMINOPHENPharbest Pharmaceuticals, Inc.e0a39957-d918-4125-88f9-0e550b976fa12025-12-24WarningsExact identifier
application number: M013
PHARBETOLACETAMINOPHEN 500MGPharbest Pharmaceuticals, Inc.27337be9-e279-460e-903e-ae44630995992025-12-24WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPUBLIX SUPERMARKETS, INC08f5af1d-365b-a97c-e063-6394a90a99ae2025-12-23WarningsExact identifier
application number: M013
ACETAMINOPHEN 500 MGACETAMINOPHENPioneer Life Sciences, LLC0d67bb52-7ae3-439e-9e47-4e21eb0ca3522025-12-23WarningsExact identifier
application number: M013
ACETAMINOPHEN 500 MGACETAMINOPHENPioneer Life Sciences, LLC11e6ec2a-5171-4496-a15f-6ff744bd1f2f2025-12-23WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198444acetaminophen 650 MG Oral TabletPSN4988c97a-af39-16a8-e063-6294a90a89931
198444acetaminophen 650 MG Oral TabletSCD4988c97a-af39-16a8-e063-6294a90a89931
198444APAP 650 MG Oral TabletSY4988c97a-af39-16a8-e063-6294a90a89931

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69729-800-24697290800242 BLISTER PACK in 1 CARTON (69729-800-24) / 12 TABLET, COATED in 1 BLISTER PACK2 blister pack2026-01-29NoNoCurrent