FDA.reportPublic FDA data

Childrens Acetaminophen Oral Suspension

Product NDC
60687-762
11-digit product format
606870762
Labeler code
60687
Product ID
60687-762_24ffe677-36c2-566c-e063-6394a90a7c00
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
American Health Packaging
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-09-06
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
Childrens Acetaminophen Oral Suspension
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
307668Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8231dd91-e9e6-4350-a485-fa95d65a6d25Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-762-17Childrens Acetaminophen Oral Suspension10 in 1 CASESUSPENSION102
60687-762-40Childrens Acetaminophen Oral Suspension5 mL in 1 CUP, UNIT-DOSESUSPENSION52
60687-762-46Childrens Acetaminophen Oral Suspension10 in 1 TRAYSUSPENSION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-762-17ML - Milliliter60687-762c3d44cf4-acf0-4f34-a30d-749cc7399aa112023-08-08
60687-762-40ML - Milliliter60687-762217cee6a-990f-4e51-b0b2-28db5932e29112023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-762CHILDRENS ACETAMINOPHEN ORAL SUSPENSION (ACETAMINOPHEN) SUSPENSION [AMERICAN HEALTH PACKAGING]2Current NDC, 3 package rows20241023_8231dd91-e9e6-4350-a485-fa95d65a6d25.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 54 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AspirinASPIRINProficient Rx LP9c186289-e309-45e8-8934-1d0eae0375c22024-12-01WarningsExact identifier
application number: M013
Childrens Chewable AcetaminophenACETAMINOPHENGERI-CARE PHARMACEUTICAL CORP22f63d62-c941-5b8f-e063-6394a90aeecd2024-11-28WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENGeri-Care Pharmaceutical Corp7a7b6318-b7d6-31b1-e053-2991aa0abf252024-11-28WarningsExact identifier
application number: M013
Extra Strength Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLINGLES MARKETS, INC.27fd288e-c07a-617f-e063-6394a90a17a42024-11-28WarningsExact identifier
application number: M013
BAYER Aspirin Original, TRAVEL BASIXASPIRINLil' Drug Store Products, Inc.7f5d9ebe-8119-49a2-9380-eca18a5e5e852024-11-27WarningsExact identifier
application number: M013
EXCEDRIN MIGRAINEACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINEJones Healthcare Group - Packaging Services, Incc4168e4d-3dfc-4e51-a32e-14704cb59c662024-11-27WarningsExact identifier
application number: M013
TYLENOL Extra Strength / TYLENOL Precise Cooling Pain ReliefACETAMINOPHEN, LIDOCAINE, MENTHOLKenvue Brands LLC2611e984-0dd5-bda1-e063-6394a90a559a2024-11-26WarningsExact identifier
application number: M013
First Aid Only Extra-Strength Non-AspirinACETAMINOPHENAcme United Corporation6891d57a-10a6-53de-e053-2a91aa0ac7c22024-11-26WarningsExact identifier
application number: M013
Chewable AspirinASPIRINMARC GLASSMAN, INC.c8314910-71ff-5a55-e053-2995a90aafc72024-11-26WarningsExact identifier
application number: M013
AspirinASPIRINMarc Glassman, Inc.7990ca49-fb30-40fe-9ac4-48e89eac9bb22024-11-26WarningsExact identifier
application number: M013
Enteric Coated Aspirin Regular StrengthASPIRINSafeway96359eb6-62bc-4b13-960c-050af99a8c022024-11-26WarningsExact identifier
application number: M013
ASPIRIN Low DoseASPIRINMarc Glassman, Inc.3d519af3-9398-4439-8253-1e5d4612b8e32024-11-26WarningsExact identifier
application number: M013
ACETAMINOPHEN (RED)ACETAMINOPHENHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.06eabf4b-f8c0-439a-acf1-aa6e3075c7172024-11-25WarningsExact identifier
application number: M013
ACETAMINOPHEN (RED)ACETAMINOPHENHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltda352f588-4a70-42b2-8f9c-a73a0629517d2024-11-25WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.5c42dd28-820c-4cc5-9016-11ad5e5806162024-11-25WarningsExact identifier
application number: M013
equate pain relieverACETAMINOPHENWALMART INC.4518fe82-3ba8-4e9e-a036-776df7fb8d572024-11-21WarningsExact identifier
application number: M013
Family Wellness Pain RelieverASPIRINFAMILY WELLNESS SERVICES, INC.075e19f4-1a58-aedd-e063-6294a90af7082024-11-20WarningsExact identifier
application number: M013
MejoralitoACETAMINOPHENOPMX Chula Vistafd2ecde0-296e-060f-e053-6294a90afd982024-11-15WarningsExact identifier
application number: M013
Temp XACETAMINOPHENOPMX Chula Vistafd2edc32-0351-c991-e053-6294a90ab4ce2024-11-15WarningsExact identifier
application number: M013
CVS Health Extra Strength Antacid and Pain RelieverASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATECVS Pharmacyafe9e755-18ba-305f-e053-2995a90aa8d02024-11-14WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN8231dd91-e9e6-4350-a485-fa95d65a6d252
307668acetaminophen 32 MG/ML Oral SuspensionSCD8231dd91-e9e6-4350-a485-fa95d65a6d252
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY8231dd91-e9e6-4350-a485-fa95d65a6d252
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY8231dd91-e9e6-4350-a485-fa95d65a6d252
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY8231dd91-e9e6-4350-a485-fa95d65a6d252
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY8231dd91-e9e6-4350-a485-fa95d65a6d252
307668APAP 32 MG/ML Oral SuspensionSY8231dd91-e9e6-4350-a485-fa95d65a6d252

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-762-176068707621710 TRAY in 1 CASE (60687-762-17) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-762-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-762-40) 10 tray2023-09-06NoNoCurrent
60687-762-40606870762405 mL in 1 CUP, UNIT-DOSE5 mlHistorical
60687-762-466068707624610 in 1 TRAYHistorical