Home NDC 69168-011 Acetaminophen 500mg
Product NDC 69168-011
11-digit product format 691680011
Labeler code 69168
Product ID 69168-011_11b91c20-790a-4874-9060-27cd40f6a34d
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen 500mg
Dosage form TABLET
Route ORAL
Labeler Allegiant Health
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-04-15
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 500mg
Brand name suffix ES
Listing expiration 2027-12-31 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.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69168-011-24 Acetaminophen 500mgES 1 in 1 CARTON TABLET 1 5 69168-011-24 Acetaminophen 500mgES 24 in 1 BOTTLE TABLET 24 5 69168-011-40 Acetaminophen 500mgES 40 in 1 BOTTLE TABLET 40 5 69168-011-40 Acetaminophen 500mgES 1 in 1 CARTON TABLET 1 5 69168-011-50 Acetaminophen 500mgES 50 in 1 BOTTLE TABLET 50 5 69168-011-50 Acetaminophen 500mgES 1 in 1 CARTON TABLET 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69168-011 ACETAMINOPHEN 500MG ES (ACETAMINOPHEN 500MG) TABLET [ALLEGIANT HEALTH] 5 Current NDC, Legacy NDC, 6 package rows 20231115_91acc132-01b6-467b-9af5-70f4dc93e087.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 37 of 79 · 1,561 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join IBUPROFEN IBUPROFEN Kroger Company bbedfc37-913d-8046-e053-2995a90af68a 2025-09-24 Warnings Exact identifier application number: M013 Xpect Pain Away Extra Strength ACETAMINOPHEN ASPIRIN CAFFEINE Cintas Corporation 1269d069-afaf-4ca5-b369-f74249a348db 2025-09-24 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN Preferred Pharmaceuticals Inc. 29214eec-860c-43f0-83c6-9ed5a9f530af 2025-09-22 Warnings Exact identifier application number: M013 ASPIRIN ASPIRIN Kroger Company bbee8ee4-e09d-3ba6-e053-2a95a90af647 2025-09-19 Warnings Exact identifier application number: M013 careone acetaminophen ACETAMINOPHEN American Sales Company 4bb696f6-a47b-4da9-9224-9aeae3e152f3 2025-09-19 Warnings Exact identifier application number: M013 Childrens Pain Relief ACETAMINOPHEN Aurohealth LLC 49a740ec-8ed4-4c76-b2d0-c13651bafa5e 2025-09-18 Warnings Exact identifier application number: M013 Extra Strength Headache Relief ACETAMINOPHEN, ASPIRIN, AND CAFFEINE Advanced Rx LLC a7ed4c76-a5b5-44f7-866f-f43790e45c78 2025-09-18 Warnings Exact identifier application number: M013 acetaminophen ACETAMINOPHEN CVS Pharmacy fc2d4367-8884-4b76-aa3e-8c35be1ace49 2025-09-18 Warnings Exact identifier application number: M013 TYLENOL Extra Strength ACETAMINOPHEN Kenvue Brands LLC ab02080a-c903-4e4a-a9f3-2b8197ed2f2b 2025-09-17 Warnings Exact identifier application number: M013 Childrens TYLENOL ACETAMINOPHEN Kenvue Brands LLC 79669930-f744-4bb1-8325-b75951489b64 2025-09-17 Warnings Exact identifier application number: M013 Pain Reliever PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL L.N.K. International, Inc. ff199db8-c7ea-4b6e-ad8b-3ceeca883d92 2025-09-15 Warnings Exact identifier application number: M013 Acetaminophen PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL FOODHOLD U.S.A., LLC fdd7ce80-d6be-41b9-affd-d024cf306b50 2025-09-12 Warnings Exact identifier application number: M013 Extra Strength Pain Reliever ACETAMINOPHEN INGLES MARKETS, INC. 3e89240b-0e27-fde4-e063-6394a90a779f 2025-09-11 Warnings Exact identifier application number: M013 Aspirin 81 mg Low Dose ASPIRIN HEB 926fe7b6-9607-469f-912f-4019891067a9 2025-09-10 Warnings Exact identifier application number: M013 Bayer Genuine Aspirin ASPIRIN Unifirst First Aid Corporation 356e4ff4-a7f1-4a50-9b86-2555e232b300 2025-09-09 Warnings Exact identifier application number: M013 Medique at Home Aspirin ASPIRIN Unifirst First Aid Corporation b5a469c1-9ab4-5bd7-e053-2995a90a86d1 2025-09-09 Warnings Exact identifier application number: M013 Medique Products Aspirin ASPIRIN Unifirst First Aid Corporation 9b28fed0-a993-ca72-e053-2995a90ac7fd 2025-09-09 Warnings Exact identifier application number: M013 Unishield Aspirin ASPIRIN Unishield ba106b20-32ac-df90-e053-2995a90adaef 2025-09-09 Warnings Exact identifier application number: M013 Medi First Pain Ache ASPIRIN,CAFFEINE Unifirst First Aid Corporation e82d02d5-3e44-a8f8-e053-2a95a90a2688 2025-09-09 Warnings Exact identifier application number: M013 Medique at Home Back Pain Relief MAGNESIUM SALICYLATE Unifirst First Aid Corporation e56c4aef-fa0b-74db-e053-2a95a90a9745 2025-09-09 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 Marketing end Sample Exclude flag Status 69168-011-24 69168001124 1 BOTTLE in 1 CARTON (69168-011-24) / 24 TABLET in 1 BOTTLE 1 bottle 2021-12-15 0000-00-00 No No Current 69168-011-40 69168001140 1 BOTTLE in 1 CARTON (69168-011-40) / 40 TABLET in 1 BOTTLE 1 bottle 2016-04-15 0000-00-00 No No Current 69168-011-50 69168001150 1 BOTTLE in 1 CARTON (69168-011-50) / 50 TABLET in 1 BOTTLE 1 bottle 2016-04-15 0000-00-00 No No Current