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 24 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Menstrual Relief Maximum StrengthACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATEUnited Natural Foods, Inc. dba UNFI807598ef-9f03-48df-b076-3ee95ef4b06c2026-01-05WarningsExact identifier
application number: M013
Pain Relief Extra Strength, Non-AspirinACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION INC1fb5e871-45fd-46fe-bf73-5192f8316e8e2026-01-02WarningsExact identifier
application number: M013
Pain Reliever Extra StrengthACETAMINOPHENValu Merchandisers Company0005aafa-08f8-4990-a54d-cc097195708f2026-01-02WarningsExact identifier
application number: M013
Extra Strength Pain RelieverACETAMINOPHENWalmart Inc.152bb455-da5b-ae13-e063-6394a90acab02026-01-01WarningsExact identifier
application number: M013
Dr. Cocoa for Children Pain and FeverACETAMINOPHENInfirst Healthcare Inc.486ea294-6d18-a907-e063-6294a90ad2842026-01-01WarningsExact identifier
application number: M013
ED APAPACETAMINOPHENEDWARDS PHARMACEUTICALS, INC.f76d5fff-ebea-40f9-aad3-4064a0c863f02025-12-31WarningsExact identifier
application number: M013
EXTRA STRENGTH PAIN RELIEFACETAMINOPHENGERI-CARE PHARMACEUTICAL CORP99ec63ef-aa28-c2fb-e053-2a95a90a9f6d2025-12-31WarningsExact identifier
application number: M013
Puregen Labs AcetaminophenACETAMINOPHENAdvanced Rx LLC474580af-f6b0-e440-e063-6394a90aaada2025-12-31WarningsExact identifier
application number: M013
Liquid AcetaminophenACETAMINOPHENLLORENS PHARMACEUTICALS INTERNATIONAL DIVISIONa7dbd4c0-53eb-4368-917b-1432c09ce6b42025-12-31WarningsExact identifier
application number: M013
Llorens Care Children AcetaminophenACETAMINOPHENLlorens Pharmaceutical International Division, Inc.2a46d7d2-293b-5024-e063-6294a90a31aa2025-12-31WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHEN CAPSULES 500MG (MINIS-RED OPAQUE)Walgreens3a801457-c5d0-b134-e063-6294a90ac5cb2025-12-31WarningsExact identifier
application number: M013
Daytime and Nighttime Severe Cold and Flu combo packACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEGenexa Inc.190c7eaf-dcd4-d314-e063-6294a90a6f332025-12-30WarningsExact identifier
application number: M013
BioElectro Extra Strength Headache ReliefACETAMINOPHEN, ASPIRIN, AND CAFFEINEGenomma Lab USA683a0fba-921c-48e7-a391-180c04f0d1c42025-12-30WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINEPioneer Life Sciences, LLC0181af13-da32-4431-be39-c31fdfac92022025-12-29WarningsExact identifier
application number: M013
Gemma Cut the CrampASPIRIN, CAFFEINERally Labs LLC16c9a296-077a-8e12-e063-6294a90a1b8b2025-12-29WarningsExact identifier
application number: M013
BlowfishASPIRIN, CAFFEINERally Labs LLC0d3798bc-04ef-584e-821b-7aa76036b7d12025-12-29WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINEPioneer Life Sciences, LLCad29a37f-39a2-5c84-e053-2995a90a2f392025-12-29WarningsExact identifier
application number: M013
Tension Headache ReliefACETAMINOPHEN, CAFFEINEPioneer Life Sciences, LLCac9efd62-8fee-b777-e053-2995a90a37832025-12-29WarningsExact identifier
application number: M013
Childrens Pain Relief and Fever Reducer Oral Suspension CherryACETAMINOPHENPuro Pharma Inc.a2afaee7-19f3-4a42-a5b8-1d0ef3ecf0092025-12-27WarningsExact identifier
application number: M013
Cystex PMACETAMINOPHEN, DIPHENHYDRAMINE HCLClarion Brands, LLC9668a2ca-729e-4172-80b5-33e6c5175ba42025-12-27WarningsExact 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