Home NDC 0485-0057 ED APAP
Product NDC 0485-0057
11-digit product format 004850057
Labeler code 0485
Product ID 0485-0057_4742634e-a794-9047-e063-6394a90a2cd3
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN
Dosage form LIQUID
Route ORAL
Labeler EDWARDS PHARMACEUTICALS, INC.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-03-07
Substance ACETAMINOPHEN
Active strength 160 mg/5mL
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 ED APAP
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 160 mg/5mL
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 307675 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0485-0057-08 ED APAP 236 mL in 1 BOTTLE, PLASTIC LIQUID 236 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D ED APAP (ACETAMINOPHEN) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D ED APAP (ACETAMINOPHEN) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP ED APAP (ACETAMINOPHEN) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ED APAP (ACETAMINOPHEN) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ED APAP (ACETAMINOPHEN) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ ED APAP (ACETAMINOPHEN) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY ED APAP (ACETAMINOPHEN) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU ED APAP (ACETAMINOPHEN) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR ED APAP (ACETAMINOPHEN) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R ED APAP (ACETAMINOPHEN) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ED APAP (ACETAMINOPHEN) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0485-0057 ED APAP (ACETAMINOPHEN) LIQUID [EDWARDS PHARMACEUTICALS, INC.] 6 Current NDC, Legacy NDC, 1 package rows 20241228_f76d5fff-ebea-40f9-aad3-4064a0c863f0.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 57 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join aspirin ASPIRIN A-S Medication Solutions 65c41c20-2f9c-4012-900b-c2ffdf665144 2024-11-06 Warnings Exact identifier application number: M013 foster and thrive pain reliever ACETAMINOPHEN Strategic Sourcing Services LLC 338021bd-b92b-45eb-a4b8-bc4a100ab718 2024-11-06 Warnings Exact identifier application number: M013 basic care headache relief ACETAMINOPHEN, ASPIRIN, CAFFEINE Amazon.com Services LLC f85d2f4c-8184-4555-a310-3979722e860b 2024-11-05 Warnings Exact identifier application number: M013 MENSTRUAL COMPLETE MENSTRUAL COMPLETE Allegiant Health d197b886-67e4-4aba-8582-305576c07604 2024-11-05 Warnings Exact identifier application number: M013 dg health headache relief ACETAMINOPHEN, ASPIRIN, CAFFEINE Dolgencorp Inc ddf40cc4-d73f-4460-be72-9486134329a7 2024-11-05 Warnings Exact identifier application number: M013 DOLO- NeuroBion Acetaminophen 500mg ACETAMINOPHEN BENARD INDUSTRIES INC 16f8415d-8190-4212-b487-c0caf7d3bee2 2024-11-04 Warnings Exact identifier application number: M013 basic care acetaminophen ACETAMINOPHEN Amazon.com Services LLC 8c3343ee-d7b6-496d-9702-6736539a7270 2024-11-02 Warnings Exact identifier application number: M013 dg health pain relief ACETAMINOPHEN Dolgencorp, LLC 382fa2cc-1c39-4bee-b528-08b11ec945af 2024-11-02 Warnings Exact identifier application number: M013 acetaminophen ACETAMINOPHEN Bryant Ranch Prepack f7e20527-1d4b-434c-997b-3eb8211fdaa1 2024-11-01 Warnings Exact identifier application number: M013 Aspirin Enteric Safety Coated ASPIRIN Publix Supermarkets, Inc. a661a9ed-9b31-46b1-aafb-61d1ba8a4918 2024-11-01 Warnings Exact identifier application number: M013 acetaminophen ACETAMINOPHEN Bryant Ranch Prepack 614e69c7-d3cb-4d47-9603-c1c14b87544c 2024-11-01 Warnings Exact identifier application number: M013 infants fever reducer and pain reliever ACETAMINOPHEN Rite Aid Corporation baee03b8-fcfd-440e-90ea-1ee2a18516ef 2024-11-01 Warnings Exact identifier application number: M013 good neighbor pharmacy infants pain and fever ACETAMINOPHEN Amerisource Bergen bfb954b7-3a79-4bca-95e8-d39e1074b07f 2024-11-01 Warnings Exact identifier application number: M013 EXTRA STRENGTH PAIN RELIEVER ACETAMINOPHEN, ASPIRIN AND CAFFEINE Proficient Rx LP bf365bfc-35cc-47f9-a50b-ff2b38d7316b 2024-11-01 Warnings Exact identifier application number: M013 Infants Pain Relief ACETAMINOPHEN Publix Super Markets Inc 0bc33897-afc2-4d11-be6c-a26480f448bf 2024-10-31 Warnings Exact identifier application number: M013 equate infants pain and fever ACETAMINOPHEN WALMART INC. 34b2512e-743b-45db-92cb-ea05e2f47b3d 2024-10-31 Warnings Exact identifier application number: M013 foster and thrive infants pain and fever ACETAMINOPHEN Strategic Sourcing Services LLC 45770ad6-9bf7-41bd-a724-e5260cd31fa1 2024-10-31 Warnings Exact identifier application number: M013 Midol Complete ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE TABLET Lil' Drug Store Products, Inc. d20425a4-f074-4154-e053-2995a90ae9fd 2024-10-30 Warnings Exact identifier application number: M013 up and up infants acetaminophen ACETAMINOPHEN Target Corporation 31104956-04d7-41b5-82be-219ded5c02a9 2024-10-30 Warnings Exact identifier application number: M013 Sunmark Aspirin ASPIRIN Strategic Sourcing Services LLC a7139686-b351-47dc-a395-832429aaa569 2024-10-30 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 0485-0057-08 00485005708 236 mL in 1 BOTTLE, PLASTIC (0485-0057-08) 236 ml 2012-03-07 0000-00-00 No No Current