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 52 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equaline Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEUnited Natural Foods, Inc. dba UNFI739237a5-cc62-8ad6-e053-2991aa0a91f82024-12-17WarningsExact identifier
application number: M013
NOTTS - Muscle Aches and PainACETAMINOPHENVIVUNT PHARMA LLCe6741300-4573-2580-e053-2a95a90a599c2024-12-17WarningsExact identifier
application number: M013
Extra Strength Pain Reliever, Caseys 4goodACETAMINOPHEN 500MG, FILM-COATED CAPLETLil' Drug Store Products, Inc.e5fc5340-c224-e02b-e053-2a95a90a52972024-12-16WarningsExact identifier
application number: M013
Pain Reliever, Caseys 4goodACETAMINOPHEN 500 MG, TABLETLil' Drug Store Products, Inc.039d2cf1-57f6-4d9d-e063-6394a90a54922024-12-16WarningsExact identifier
application number: M013
Extra Strength Headache, Caseys 4goodACETAMINOPHEN, ASPIRIN, CAFFEINE TABLETLil' Drug Store Products, Inc.0425c6a8-a3ea-24ad-e063-6294a90ae15a2024-12-16WarningsExact identifier
application number: M013
Lil Drug Store Childrens Pain and FeverACETAMINOPHENLil' Drug Store Products, Inc.5fcd41ad-449f-4090-be19-eae4171de8912024-12-16WarningsExact identifier
application number: M013
Acetaminophen 250mg Aspirin 250mg Caffeine 65mgACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MGCVS Pharmacyb9e75551-1e50-9896-e053-2a95a90aafd42024-12-14WarningsExact identifier
application number: M013
Acetaminophen 250mg Aspirin 250mg Caffeine 65mgACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MGCVS Pharmacyb9e5df0e-06d3-6f72-e053-2995a90a2d072024-12-14WarningsExact identifier
application number: M013
Alka-Seltzer Heartburn and PainANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATEBayer HealthCare LLC.2928e140-c868-5bf5-e063-6394a90ab0242024-12-13WarningsExact identifier
application number: M013
foster and thrive pain relieverACETAMINOPHENStrategic Sourcing Services LLCb8ee568c-80cf-4e35-865e-35516bdab0fd2024-12-13WarningsExact identifier
application number: M013
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEStrive Pharmaceuticals Inc.c0de0bd2-4868-46dc-a20f-3ca02caaa26b2024-12-11WarningsExact identifier
application number: M013
Rite Aid Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATERite Aidb4797380-9cef-d640-e053-2a95a90a06652024-12-11WarningsExact identifier
application number: M013
Top Value Effervescent Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICAROBONATETower Laboratories Ltd44babed8-cf38-1c12-e054-00144ff8d46c2024-12-11Warnings, Adverse reactionsExact identifier
application number: M013
Best Choice Effervescent Antacid Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEValu Merchandisers Companyb5e2300a-b77b-53cc-e053-2a95a90a7a6e2024-12-11WarningsExact identifier
application number: M013
EXTRA STRENGTH Headache Relief geltabsACETAMINOPHEN, ASPIRIN, CAFFEINEStrive Pharmaceuticals Inc.b432771a-4f7d-4d39-a038-d1561d8f67082024-12-11WarningsExact identifier
application number: M013
Pain Relief ChildrensACETAMINOPHENQUALITY CHOICE (Chain Drug Marketing Association)223ffb2b-3ee5-4118-955b-bc4fa4e8a2e62024-12-10WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENUNFIe689c9e3-dd4d-c646-e053-2a95a90a4b6a2024-12-09WarningsExact identifier
application number: M013
DrKids Childrens Pain and FeverACETAMINOPHEN 80MG/PIECECalmCo LLCff4b0528-39a0-80d5-e053-6394a90a8a832024-12-07WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDISCOUNT DRUG MART972f09a7-2aa1-4b1b-a6dc-2c4578a078032024-12-05WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENDISCOUNT DRUG MARTe6feff0a-3347-194d-e053-2a95a90acd202024-12-05WarningsExact 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