NDC 68094-587-59 - 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
68094-587
Requested NDC
68094-587-59
Package NDCs from labels
68094-587-58, 68094-587-59, 68094-587-62, 68094-587-61
Manufacturer
Precision Dose Inc.
Effective date
2022-09-12
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.2022-09-12HUMAN OTC DRUG LABEL
Childrens Acetaminophen - Cardinal HealthCardinal Health2020-05-20HUMAN OTC DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-587-58ML - Milliliter68094-58714529737-7c59-46b4-8359-299a85dd496112014-06-03
68094-587-59ML - Milliliter68094-58799afddc2-b1ef-479d-8165-05285174dd2a12014-06-03
68094-587-61ML - Milliliter68094-587e15c6260-04f1-4480-8f82-b7e08cfd98f412014-06-03
68094-587-62ML - Milliliter68094-587917251eb-e7b2-485c-b293-37cb8362267512014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [CARDINAL HEALTH]1
AcetaminophenACTIVE INGREDIENT362O9ITL9DCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]1
AcetaminophenACTIVE MOIETY362O9ITL9DCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]1
AcetaminophenACTIVE MOIETY362O9ITL9DCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [CARDINAL HEALTH]1
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]1
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [CARDINAL HEALTH]1
butylparabenINACTIVE INGREDIENT3QPI1U3FV8CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]1
butylparabenINACTIVE INGREDIENT3QPI1U3FV8CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [CARDINAL HEALTH]1
calcium sulfateINACTIVE INGREDIENTWAT0DDB505CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]1
calcium sulfateINACTIVE INGREDIENTWAT0DDB505CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [CARDINAL HEALTH]1
carboxymethylcellulose sodiumINACTIVE INGREDIENTK679OBS311CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [CARDINAL HEALTH]1
carboxymethylcellulose sodiumINACTIVE INGREDIENTK679OBS311CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]1
carrageenanINACTIVE INGREDIENT5C69YCD2YJCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]1
carrageenanINACTIVE INGREDIENT5C69YCD2YJCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [CARDINAL HEALTH]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [CARDINAL HEALTH]1
D&C red no. 33INACTIVE INGREDIENT9DBA0SBB0LCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]1
D&C red no. 33INACTIVE INGREDIENT9DBA0SBB0LCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [CARDINAL HEALTH]1
FD&C blue no. 1INACTIVE INGREDIENTH3R47K3TBDCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]1
FD&C blue no. 1INACTIVE INGREDIENTH3R47K3TBDCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [CARDINAL HEALTH]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [CARDINAL HEALTH]1
high fructose corn syrupINACTIVE INGREDIENTXY6UN3QB6SCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]1
high fructose corn syrupINACTIVE INGREDIENTXY6UN3QB6SCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [CARDINAL HEALTH]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [CARDINAL HEALTH]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [CARDINAL HEALTH]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]1
sodium phosphate, tribasicINACTIVE INGREDIENTA752Q30A6XCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]1
sodium phosphate, tribasicINACTIVE INGREDIENTA752Q30A6XCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [CARDINAL HEALTH]1
sorbitolINACTIVE INGREDIENT506T60A25RCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]1
sorbitolINACTIVE INGREDIENT506T60A25RCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [CARDINAL HEALTH]1
waterINACTIVE INGREDIENT059QF0KO0RCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]1
waterINACTIVE INGREDIENT059QF0KO0RCHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [CARDINAL HEALTH]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 7 of 210 · 4,182 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Overnight Cold and Flu Clear and CoolACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDECVS PHARMACY, INC2497a011-d7a0-4d69-97e2-bbf25a99b1cc2026-08-17WarningsExact identifier
unii: 362O9ITL9D
Mucus Relief Cough Cold Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLH E B3ef949f5-ac8c-44be-b04d-6996fa59a94b2026-08-17WarningsExact identifier
unii: 362O9ITL9D
Sinus PE Head Congestion and MucusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLBetter Living Brands, LLC28a4ec37-11dd-4134-81aa-851f081bf0882026-08-17WarningsExact identifier
unii: 362O9ITL9D
CVS Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLCVS HEALTHf01ab8ef-d29a-4e33-8a14-4c57ccdcc0d62026-08-17WarningsExact identifier
unii: 362O9ITL9D
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEARMY AND AIR FORCE EXCHANGE SERVICE77f87e19-a9d5-479d-9434-bbde13210bfb2026-08-15WarningsExact identifier
unii: 362O9ITL9D
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECardinal Health 110, LLC. DBA Leaderb1c2055b-4b5a-4fa2-b600-8930c9c8524c2026-08-15WarningsExact identifier
unii: 362O9ITL9D
Nighttime HBP Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS PHARMACY146c9a62-0418-4b5d-9074-5be8a05f3f932026-08-15WarningsExact identifier
unii: 362O9ITL9D
Pain Relief ChildrensACETAMINOPHENWinCo Foods, LLC15921c3f-e8d4-4794-983f-63bb926f6f862026-08-15WarningsExact identifier
application number: M013
rxcui: 307668
unii: 362O9ITL9D
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leader610accad-2f8b-4605-9357-a58e6e18d4172026-08-15WarningsExact identifier
unii: 362O9ITL9D
Cold and Flu NightACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWalgreen Company32c67914-d7cf-40ee-8682-0ba8ed6912872026-08-15WarningsExact identifier
unii: 362O9ITL9D
Childrens Pain plus Fever ReliefACETAMINOPHENCVS PHARMACYe4cbfb06-d826-4d08-95d6-60305c4176252026-08-14WarningsExact identifier
application number: M013
rxcui: 307668
unii: 362O9ITL9D
CVS Childrens COLD PLUS COUGH PLUS SORE THROATACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDECVS PHARMACY27820bce-6638-4f17-ac66-62b02b76bec32026-08-14WarningsExact identifier
unii: 362O9ITL9D
CVS Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDE AND ACETAMINOPHENCVS PHARMACY333e170e-52cd-4218-8d15-0bf3c5c75cb92026-08-14WarningsExact identifier
unii: 362O9ITL9D
CVS NightTime ColdACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY0f0cc40d-7939-4d4d-a931-b4de4070fea12026-08-14WarningsExact identifier
unii: 362O9ITL9D
Childrens Pain ReliefACETAMINOPHENCVS Pharmacy,Inc.3738d35c-1e83-40df-9292-c54e6b2c83532026-08-14WarningsExact identifier
application number: M013
unii: 362O9ITL9D
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
BM BM164 DROPSARUM TRYPH, CAUSTICUM, BALSAMUM PERU, HELONIAS DIO, ACID PHOS, GLYCERINUM, EQUISETUMBM Private Limited5902770f-eb01-d099-e063-6394a90ad3eb2026-08-14WarningsExact identifier
unii: PDC6A3C0OX
Oxycodone Hydrochloride and AcetaminophenOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacy40a68a27-4422-5ba0-e063-6294a90ac5502026-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Theraflu Relief Max Strength NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBRCVS PHARMACY4b567234-1da9-4e10-a427-877eea2be1c12026-08-14WarningsExact identifier
unii: 362O9ITL9D
CVS Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS PHARMACY87d4cfc0-c7b4-42c0-bfa9-96e124e32ed32026-08-14WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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