Childrens Pain and Fever

Product NDC
76162-079
11-digit product format
761620079
Labeler code
76162
Product ID
76162-079_05447f58-f56f-4a85-83d9-350d085e3de9
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
TOPCO ASSOCIATES LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-12-29
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 Pain and Fever
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
bbc367cc-6c79-498e-8fca-1347e6ea1a8cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-079-36Childrens Pain and Fever1 in 1 CARTONSUSPENSION13
76162-079-36Childrens Pain and Fever118 mL in 1 BOTTLE, PLASTICSUSPENSION1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-079CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]2Current NDC, 2 package rows20241012_bbc367cc-6c79-498e-8fca-1347e6ea1a8c.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 17 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AspirinASPIRINCardinal Health 110, LLC. DBA Leader318cc982-23a9-4804-b6fb-248f772d7a382026-04-02WarningsExact identifier
application number: M013
Chewable Acetaminophen ChildrensACETAMINOPHENCardinal Health 110, LLC. DBA Leader8a18565c-b84e-43f8-8e96-e1dbcc39f08b2026-04-02WarningsExact identifier
application number: M013
Childrens Pain RelieverACETAMINOPHENH E Bc713556c-cb9e-4ed2-bc2f-49b3d6256c0f2026-04-02WarningsExact identifier
application number: M013
AspirinASPIRINDiscount Drug Mart4a1e9c79-5036-4c69-82f9-e48abc972b472026-04-02WarningsExact identifier
application number: M013
WispirinASPIRINWisdrug AG4e70ec5e-d033-a525-e063-6394a90a5a932026-04-01WarningsExact identifier
application number: M013
Aspirin RegimenASPIRINCardinal Health 110, LLC. DBA Leaderef2d75ee-9ed7-4b53-adbc-2ec40364da632026-03-31WarningsExact identifier
application number: M013
Tension Headache ReliefACETAMINOPHEN, CAFFEINEHi-Tech Nutraceuticals, LLCb119ba37-0ee3-851a-e053-2995a90a85b12026-03-31WarningsExact identifier
application number: M013
AspirinASPIRINRMT HEALTH LLC4dc7229d-c895-1f80-e063-6394a90abfc32026-03-30WarningsExact identifier
application number: M013
AspirinASPIRINPD-Rx Pharmaceuticals, Inc.d1f05e56-c830-4f85-b685-2a5965d10a1c2026-03-26WarningsExact identifier
application number: M013
M-PAPACETAMINOPHENBryant Ranch Prepackad01aea6-4af3-469b-b99d-e1e66aa40e8d2026-03-25WarningsExact identifier
application number: M013
aspirinASPIRINMeijer Distribution Incc550b92e-de54-4599-9534-bd3022b0a86d2026-03-25WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINAmerisourceBergen (Good Neighbor Pharmacy) 46122db187226-0770-4934-90a4-c6ca50bdecef2026-03-25WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)804d4b63-1bbe-47c0-ad49-39ddbeade6a32026-03-25WarningsExact identifier
application number: M013
childrens pain and feverACETAMINOPHENHyVee Inc9d9c2bf6-8660-4987-8794-936d3102da8d2026-03-24WarningsExact identifier
application number: M013
Childrens Pain RelieverACETAMINOPHENBJWC (Berkley & Jensen / BJ's)851228ea-eaf3-452b-a9ce-8cd244a0eaf32026-03-24WarningsExact identifier
application number: M013
FirstCare Childrens Pain Fever AcetaminophenACETAMINOPHEN 80 MGUSpharma Ltd9fc05ba6-5667-457e-82c1-a8b4e16cadda2026-03-23WarningsExact identifier
application number: M013
AspirinASPIRINAarkish Pharmaceuticals NJ Inc.e5e9e1ce-666a-461f-8287-a4642902067c2026-03-23WarningsExact identifier
application number: M013
Chewable Aspirin Low DoseCHEWABLE ASPIRINGrocery Outlet609c0389-8bed-4483-84fa-73ee73fdb4e42026-03-20WarningsExact identifier
application number: M013
Adult Low Dose Pain RelieverASPIRINTWIN MED LLCa395acf4-f487-4c98-8c44-ca2aaaf72deb2026-03-20WarningsExact identifier
application number: M013
RapidolACETAMINOPHENPharmadel LLC3a210860-1fc1-e496-e063-6394a90a87052026-03-20WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNbbc367cc-6c79-498e-8fca-1347e6ea1a8c3
307668acetaminophen 32 MG/ML Oral SuspensionSCDbbc367cc-6c79-498e-8fca-1347e6ea1a8c3
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYbbc367cc-6c79-498e-8fca-1347e6ea1a8c3
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYbbc367cc-6c79-498e-8fca-1347e6ea1a8c3
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYbbc367cc-6c79-498e-8fca-1347e6ea1a8c3
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYbbc367cc-6c79-498e-8fca-1347e6ea1a8c3
307668APAP 32 MG/ML Oral SuspensionSYbbc367cc-6c79-498e-8fca-1347e6ea1a8c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
76162-079-36761620079361 BOTTLE, PLASTIC in 1 CARTON (76162-079-36) / 118 mL in 1 BOTTLE, PLASTIC2022-12-29NoNoCurrent