Home NDC 72090-038-01 ACETAMINOPHEN 500 MG
Product NDC 72090-038
Requested package NDC 72090-038-01
11-digit product format 720900038
Labeler code 72090
Product ID 72090-038_e622e006-df18-4e5d-ae1b-03e1bea9bf21
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN
Dosage form TABLET
Route ORAL
Labeler Pioneer Life Sciences, LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-01-09
Substance ACETAMINOPHEN
Active strength 500 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 ACETAMINOPHEN 500 MG
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72090-038-01 ACETAMINOPHEN 500 MG 500 in 1 BOTTLE TABLET 500 1 72090-038-02 ACETAMINOPHEN 500 MG 300 in 1 PACKAGE TABLET 300 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72090-038 ACETAMINOPHEN 500 MG (ACETAMINOPHEN) TABLET [PIONEER LIFE SCIENCES, LLC] 1 Current NDC, 2 package rows 20250110_e817bc4a-43ef-4126-b903-aabd1390cd0c.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 76 of 79 · 1,576 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Acetaminophen Extra Strength ACETAMINOPHEN Aurohealth LLC 03d42892-4465-4089-90a7-cd5f00c35602 2023-11-29 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN Aurohealth LLC 57bb1acc-b9a0-48cd-8e5c-33712441ce81 2023-11-29 Warnings Exact identifier application number: M013 Acetaminophen Regular Strength ACETAMINOPHEN Aurohealth LLC cc0ab7a1-e535-4dc8-962f-c58949fc1737 2023-11-29 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Aurohealth LLC a4ff94b9-c248-4cd3-8491-38e9555cc22e 2023-11-29 Warnings Exact identifier application number: M013 Aurophen Extra Strength for Adults ACETAMINOPHEN Aurohealth LLC d59c5f04-4bcc-4a52-a42f-e049506f00de 2023-11-29 Warnings Exact identifier application number: M013 Aurophen Extra Strength for Adults ACETAMINOPHEN Aurohealth LLC a769094b-1e91-4ca7-ba67-21aa7e312910 2023-11-29 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Aurohealth LLC 30756257-f748-4a5d-b031-dd267d0f91ad 2023-11-29 Warnings Exact identifier application number: M013 Aurophen Regular Strength ACETAMINOPHEN Aurohealth LLC 8eda893f-5266-4b7a-95b9-2e194973cf06 2023-11-29 Warnings Exact identifier application number: M013 Childrens Pain Relief ACETAMINOPHEN Aurohealth LLC 00ec6518-b5e3-49d1-a342-139381c3bfd2 2023-11-29 Warnings Exact identifier application number: M013 CHILDRENS PAIN RELIEF ACETAMINOPHEN Better Living Brands, LLC fadb4c09-071f-56c0-e053-6294a90ae6c1 2023-11-28 Warnings Exact identifier application number: M013 Acetaminophen and Diphenhydramine hydrochloride ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE Better Living Brands, LLC fc07d516-9ffe-9989-e053-6294a90ae1a5 2023-11-28 Warnings Exact identifier application number: M013 NOTTS - Tension Headache ACETAMINOPHEN, CAFFEINE VIVUNT PHARMA LLC 08f2ae03-967b-ad7e-e063-6294a90a8484 2023-11-24 Warnings Exact identifier application number: M013 Sanatos Multi Symptoms Nighttime ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE Pharmadel LLC 0a60326a-a17b-e843-e063-6394a90ac211 2023-11-22 Warnings Exact identifier application number: M013 Sanatos Nighttime Multi Symptoms ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE Pharmadel LLC 0ab188f3-f7f9-d665-e063-6294a90a198a 2023-11-22 Warnings Exact identifier application number: M013 ASPIRIN ASPIRIN TIME CAP LABS INC fe12519c-3e5f-4592-bd34-2d6b81b981f4 2023-11-22 Warnings Exact identifier application number: M013 Rugby Regular Strength Acetaminophen ACETAMINOPHEN A-S Medication Solutions 400d4a29-9e39-4e74-8272-37be5d789924 2023-11-22 Warnings Exact identifier application number: M013 RIGHT REMEDIES Pain Relief Extra Strength Caplet ACETAMINOPHEN Strive Pharmaceuticals Inc. dcce28d9-8528-489e-b995-1d98e9d0e6ad 2023-11-21 Warnings Exact identifier application number: M013 Sanatos Multi Symptom Daytime ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI Pharmadel LLC 0ab11691-5b29-55fc-e063-6394a90aa328 2023-11-17 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN A-S Medication Solutions 1e223faa-f6d0-4235-bc4c-6cfca84a5b0a 2023-11-17 Warnings Exact identifier application number: M013 SanaTos X ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCI Pharmadel LLC 85b8ef3d-7318-7f3b-e053-2991aa0a0777 2023-11-14 Warnings Exact identifier application number: M013
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72090-038-01 72090003801 500 TABLET in 1 BOTTLE (72090-038-01) 500 tablet 2025-01-09 No No Current