FDA.reportPublic FDA data

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
IngredientStrength
ACETAMINOPHEN160 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
307675Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f76d5fff-ebea-40f9-aad3-4064a0c863f0Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-08-10Ed-EdAPAPChild 0057
2023-07-28Ed-EdAPAPChild 0057
2020-04-08Ed-EdAPAPChild 0057
2020-01-31Ed-EdAPAPChild 0057

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0485-0057-08ED APAP236 mL in 1 BOTTLE, PLASTICLIQUID2367

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0485-0057-08ML - Milliliter0485-00577b26afc0-0dc5-4bbc-9c56-7f3aecd41bfd12013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DED APAP (ACETAMINOPHEN) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DED APAP (ACETAMINOPHEN) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPED APAP (ACETAMINOPHEN) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAED APAP (ACETAMINOPHEN) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXED APAP (ACETAMINOPHEN) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQED APAP (ACETAMINOPHEN) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYED APAP (ACETAMINOPHEN) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUED APAP (ACETAMINOPHEN) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRED APAP (ACETAMINOPHEN) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RED APAP (ACETAMINOPHEN) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RED APAP (ACETAMINOPHEN) LIQUID [EDWARDS PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0485-0057ED APAP (ACETAMINOPHEN) LIQUID [EDWARDS PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 1 package rows20241228_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 42 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens AcetaminophenACETAMINOPHENBryant Ranch Prepack190bb2dc-92b4-4b59-a47f-a0251df8261c2025-07-29WarningsExact identifier
application number: M013
Extra Strength NiteTime Pain ReliefACETAMINOPHEN 500 MG,DIPHENHYDRAMINE HYDROCHLORIDE 25 MG TABLETWALGREENSc25c75c7-157f-1c0d-e053-2995a90a2e3c2025-07-25WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEWalmart Inc.21ab3d58-bb0e-3e51-e063-6294a90ad4152025-07-25WarningsExact identifier
application number: M013
Childrens TYLENOLACETAMINOPHENKenvue Brands LLC3a935584-6045-0a58-e063-6394a90a40c42025-07-23WarningsExact identifier
application number: M013
DR. SANA PAIN AND FEVER FOR ChildrenACETAMINOPHENGADAL Laboratories, Inc8a22a5ba-8623-4cca-8723-52b4954034612025-07-23WarningsExact identifier
application number: M013
DuralginaACETAMINOPHENMenper Distributors Inc.bb31f66c-80a9-4bdb-983b-cef5d21de5ff2025-07-22WarningsExact identifier
application number: M013
GesteiraACETAMINOPHENMenper Distributors, Inc.5a907289-564c-491b-98d5-d7f43eaaa1b22025-07-22WarningsExact identifier
application number: M013
Extra strength Acetaminophen PMACETAMINOPHEN 500MG/ DIPHENHYDRAMINE HCL 25MGTIME CAP LABS INC010c5c98-fc67-a9c3-e063-6394a90aa6402025-07-21WarningsExact identifier
application number: M013
childrens pain and feverACETAMINOPHENMeijer Distribution Inc44d50d79-6e47-429f-8cbe-6fcac46677322025-07-18WarningsExact identifier
application number: M013
ADWE Childrens Pain FeverACETAMINOPHENRARITAN PHARMACEUTICALS INC79a3232f-0211-4c8a-acee-4f87e06ffc262025-07-17WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWalmart Inc.24d191ca-a0c4-e1a8-e063-6394a90a7a2a2025-07-16WarningsExact identifier
application number: M013
EXTRA STRENGTH HEADACHE RELIEFACETAMINOPHEN ASPIRIN CAFFEINEWAL-MART STORES INCd97073cd-b5d7-8c09-e053-2a95a90a89382025-07-16WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENBETTER LIVING BRANDS LLC.f3005d0c-424e-0ab3-e053-2995a90a1c102025-07-16WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDemoulas Super Markets, Inc397fa6e1-37b2-8f51-e063-6394a90a7b942025-07-16WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDemoulas Super Markets, Inc39800c27-f39f-cd60-e063-6394a90acd552025-07-16WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDemoulas Super Markets, Inc397f2b63-733e-5b44-e063-6394a90a97182025-07-16WarningsExact identifier
application number: M013
EXTRA STRENGTH PAIN RELIEFACETAMINOPHEN, ASPIRIN, CAFFEINEBETTER LIVING BRANDS, LLCeb6026d5-d88a-f6b3-e053-2a95a90a5b202025-07-15WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDESafewayf9597abc-3f01-4b94-8078-228e0b74677e2025-07-15WarningsExact identifier
application number: M013
Berkley and Jensen Pain ReliefACETAMINOPHENBJWCd3ee3341-93b8-487c-921e-2892d213efbb2025-07-15WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINECVS Pharmacy9e459853-5951-4ae7-88a6-85b502e9dd412025-07-14WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307675acetaminophen 160 MG in 5 mL Oral SolutionPSNf76d5fff-ebea-40f9-aad3-4064a0c863f07
307675acetaminophen 32 MG/ML Oral SolutionSCDf76d5fff-ebea-40f9-aad3-4064a0c863f07
307675acetaminophen 160 MG per 5 ML Oral SolutionSYf76d5fff-ebea-40f9-aad3-4064a0c863f07
307675acetaminophen 325 MG per 10.15 ML Oral SolutionSYf76d5fff-ebea-40f9-aad3-4064a0c863f07
307675acetaminophen 650 MG per 20.3 ML Oral SolutionSYf76d5fff-ebea-40f9-aad3-4064a0c863f07
307675acetaminophen 80 MG per 2.5 ML Oral SolutionSYf76d5fff-ebea-40f9-aad3-4064a0c863f07
307675APAP 32 MG/ML Oral SolutionSYf76d5fff-ebea-40f9-aad3-4064a0c863f07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0485-0057-0800485005708236 mL in 1 BOTTLE, PLASTIC (0485-0057-08) 236 ml2012-03-070000-00-00NoNoCurrent