FDA.reportPublic FDA data

Pain and Fever

Product NDC
59779-785
11-digit product format
597790785
Labeler code
59779
Product ID
59779-785_9af3abfc-6f70-4f14-a325-d8b60390122a
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
CVS Pharmacy
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-08-31
Marketing end
2027-01-31
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
No
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
Pain and Fever
Brand name suffix
Childrens

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
f6bbce1c-9790-4ca4-847f-579c594ffe0bAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59779-785-082023-10-09C16284748780-1f386c649-efd5-0266-e053-dadaa90a7c1aDrug Facts
59779-785-082023-01-30C16284748780-1f386c649-efd5-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-785-08Pain and FeverChildrens237 mL in 1 BOTTLE, PLASTICSUSPENSION2376
59779-785-08Pain and FeverChildrens1 in 1 BOXSUSPENSION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-785-08ML - Milliliter59779-7856c64a9ad-638b-47eb-9e2c-5ad6126a551512018-03-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DPAIN AND FEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPAIN AND FEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPAIN AND FEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8PAIN AND FEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]1
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMINACTIVE INGREDIENTK679OBS311PAIN AND FEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPAIN AND FEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPAIN AND FEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SPAIN AND FEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PAIN AND FEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPAIN AND FEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]1
SORBITOLINACTIVE INGREDIENT506T60A25RPAIN AND FEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4PAIN AND FEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]1
WATERINACTIVE INGREDIENT059QF0KO0RPAIN AND FEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEPAIN AND FEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-785PAIN AND FEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]5Current NDC, Legacy NDC, 2 package rows20231010_f6bbce1c-9790-4ca4-847f-579c594ffe0b.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 29 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Regular Strength Pain ReliefACETAMINOPHENVALU MERCHANDISERS COMPANYf7e87eac-59fb-4a72-b5c6-02953112be6a2025-12-11WarningsExact identifier
application number: M013
AspirinASPIRINVALU MERCHANDISERS COMPANY049ec1aa-66b3-9273-e063-6294a90a221b2025-12-11WarningsExact identifier
application number: M013
Aspirin 325ASPIRINWalgreen Companyf7a5d612-443c-4701-ad3b-8eb53c87bece2025-12-11WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharma355a094c-bed9-4959-8cf0-619f0e2461052025-12-11WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharmafac4e0c6-684f-45a1-99f2-de4de4017cc82025-12-11WarningsExact identifier
application number: M013
Pain Reliever PM extra strengthACETAMINOPHEN DIPHENHYDRAMINE HCLP & L Development, LLC90eba2e8-52c3-43f5-ba93-4a520368c7f42025-12-11WarningsExact identifier
application number: M013
Midol Complete, Travel BASIXACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATELil' Drug Store Products, Incd6d47af8-5f8c-4c8c-a8c6-aa214ec23bca2025-12-10WarningsExact identifier
application number: M013
Tylenol PM Extra Strength, CVP HEALTHACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDELil' Drug Store Products, Inc.643371f2-e330-441e-8932-b3aec4b179d22025-12-10WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINUnited Natural Foods, Inc. dba UNFI18b79449-5c4c-41ce-9609-80f5efa0375c2025-12-09WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENAAA Pharmaceutical, Inc.36ad34f4-4e66-f371-e063-6394a90ae76a2025-12-09WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENLIDL US LLCec543339-20ab-2cba-e053-2995a90ac7402025-12-09WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION, INC.c57c10fc-f182-4153-8974-ef359a5f5ac12025-12-09WarningsExact identifier
application number: M013
Pain Relief PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEHEBf7958347-4e9c-4698-8749-7ca7023ee2ba2025-12-09WarningsExact identifier
application number: M013
Pain Relief Rapid Release Gelcaps Extra StrengthACETAMINOPHENSafewayc830d1ac-c4c5-4eb1-98bb-22707cb6db912025-12-09WarningsExact identifier
application number: M013
Menstrual Pain Relief CompleteACETAMINOPHEN, PYRILAMINE MALEATE, CAFFEINEShield Pharmaceuticals Corp5efd6c61-74ed-4253-896a-e4a40bd8f25b2025-12-09WarningsExact identifier
application number: M013
Excedrin Extra Strength, TRAVEL BASIXACETAMINOPHEN, ASPIRIN, AND CAFFEINELil Drug Store Products, Inc7f0f8b3c-c226-4a3a-af46-a708f345e4f52025-12-09WarningsExact identifier
application number: M013
childrens acetaminophenACETAMINOPHENUnited Natural Foods, Inc. dba UNFIf65203a2-64f0-4138-97e4-6eab991941782025-12-09WarningsExact identifier
application number: M013
Pain Reliever PM, Extra Strength, 24-7 Life by 7-ElevenACETAMINOPHEN, DIPHENHYDRAMINE HCL TABLET, FILM COATEDLil' Drug Store Products, Inc.45735cd8-ac07-3f12-e063-6294a90a0cb22025-12-08WarningsExact identifier
application number: M013
BERKLEY AND JENSEN RAPID RELEASE ACETAMINOPHENACETAMINOPHENBJWCe27b6637-ef32-44b5-a531-b6617d02fbbf2025-12-08WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWALGREENS3f9f1740-9e8b-6a2d-e063-6294a90a67cb2025-12-06WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNf6bbce1c-9790-4ca4-847f-579c594ffe0b6
307668acetaminophen 32 MG/ML Oral SuspensionSCDf6bbce1c-9790-4ca4-847f-579c594ffe0b6
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYf6bbce1c-9790-4ca4-847f-579c594ffe0b6
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYf6bbce1c-9790-4ca4-847f-579c594ffe0b6
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYf6bbce1c-9790-4ca4-847f-579c594ffe0b6
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYf6bbce1c-9790-4ca4-847f-579c594ffe0b6
307668APAP 32 MG/ML Oral SuspensionSYf6bbce1c-9790-4ca4-847f-579c594ffe0b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59779-785-08597790785081 BOTTLE, PLASTIC in 1 BOX (59779-785-08) / 237 mL in 1 BOTTLE, PLASTIC2015-08-312027-01-31NoNoCurrent