FDA.reportPublic FDA data

NDC 68094-588-59 - Childrens Acetaminophen

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68094-588
Requested NDC
68094-588-59
Package NDCs from labels
68094-588-59, 68094-588-62
Manufacturer
Precision Dose Inc.
Effective date
2020-03-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CHILDREN'S ACETAMINOPHEN ORAL SUSPENSIONPrecision Dose Inc.2020-03-20HUMAN OTC DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-588-59ML - Milliliter68094-5883c77dc69-e451-43c1-b0ff-66aa3dee612412014-06-03
68094-588-62ML - Milliliter68094-588e81cec15-80e1-4d81-9024-e677b82f7ba812014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]1
AcetaminophenACTIVE MOIETY362O9ITL9DCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]1
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]1
butylparabenINACTIVE INGREDIENT3QPI1U3FV8CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]1
calcium sulfateINACTIVE INGREDIENTWAT0DDB505CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]1
carboxymethylcellulose sodiumINACTIVE INGREDIENTK679OBS311CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]1
carrageenanINACTIVE INGREDIENT5C69YCD2YJCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]1
D&C red NO. 33INACTIVE INGREDIENT9DBA0SBB0LCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]1
FD&C blue NO. 1INACTIVE INGREDIENTH3R47K3TBDCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]1
high fructose corn syrupINACTIVE INGREDIENTXY6UN3QB6SCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]1
sodium phosphate, tribasicINACTIVE INGREDIENTA752Q30A6XCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]1
sorbitolINACTIVE INGREDIENT506T60A25RCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]1
waterINACTIVE INGREDIENT059QF0KO0RCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]1

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 6 of 210 · 4,181 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
aspirin chewable, low doseASPIRINUnited Natural Foods, Inc. dba UNFI6a6ac7fe-91a4-4b55-979a-b53b51505d8b2026-08-19WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HCLStrategic Sourcing Services LLCb3baf939-a9fd-47ac-9bc7-68435e32ea1e2026-08-19WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENSam's West Inc1098d0e7-8202-4018-a2d2-b0c80ee58b562026-08-19WarningsExact identifier
application number: M013
unii: 362O9ITL9D
CVS Childrens Cold plus Cough plus Runny NoseACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDECVS7dc30e46-e289-40fc-b217-b123fee5daee2026-08-19WarningsExact identifier
unii: 362O9ITL9D
nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLAmazon.com Services LLC2517b241-c433-440f-999d-5a32d5bbaa262026-08-19WarningsExact identifier
unii: 362O9ITL9D
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINESafeway, Inc.5e77dca4-2ff8-4a8c-94bd-f224b680ca232026-08-19WarningsExact identifier
application number: M013
unii: 362O9ITL9D
dg health pain relief pm extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLDolgencorp Inc4d1eddf0-eff7-4c47-b312-30dee08d9e5f2026-08-19WarningsExact identifier
application number: M013
unii: 362O9ITL9D
CareOne 8 Hour Pain ReliefACETAMINOPHENAmerican Sales Company9b2b0ef0-7071-4536-8f74-8f1d6250e1052026-08-19WarningsExact identifier
unii: 362O9ITL9D
CVS Maximum Strength Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCLCVS PHARMACYe1c246a4-7a8c-4761-ab26-13b5165029cc2026-08-19WarningsExact identifier
unii: 362O9ITL9D
CVS Childrens Nighttime Multi Symptom ColdACETAMINOPHEN , DIPHENHYDRAMINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY9b244ac8-4ca7-43a0-b328-88f15f0fcc9d2026-08-19WarningsExact identifier
unii: 362O9ITL9D
CVS Severe Congestion and Pain ReliefACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECVS5a8e4320-bae1-4831-b66b-9babfe8888d62026-08-19WarningsExact identifier
unii: 362O9ITL9D
CVS Severe Tussin CF MaxACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS PHARMACYe32881f5-2bb5-4756-aa86-a09473ab590b2026-08-19WarningsExact identifier
unii: 362O9ITL9D
Headache Formula Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEARMY AND AIR FORCE EXCHANGE SERVICEee8d0961-7572-471f-8c96-b4c0bd354de22026-08-18WarningsExact identifier
application number: M013
unii: 362O9ITL9D
CVS Daytime Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCLCVS PHARMACY558b7ed6-a9f6-452c-90cd-df8258663bf12026-08-18WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENRugby Laboratories76f10ee2-1d6a-097c-e053-2991aa0af5262026-08-18WarningsExact identifier
application number: M013
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENMajor Pharmaceuticals780aad35-d0f1-44b1-e053-2991aa0af9a72026-08-18WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: 6DC9Q167V3
CHILDRENS PAIN AND FEVERACETAMINOPHENAmazon.com Services LLC5eacbc4f-d20a-4c22-9680-4a648e24de432026-08-18WarningsExact identifier
application number: M013
rxcui: 307668
unii: 362O9ITL9D
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.