Dye Free Pain Reliever

Product NDC
21130-285
11-digit product format
211300285
Labeler code
21130
Product ID
21130-285_7bb2ab2e-d891-4d39-a142-39a18d483059
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Safeway, Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-06-30
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
Dye Free Pain Reliever
Brand name suffix
Childrens
Listing expiration
2027-12-31

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
7d55cb42-295f-473a-941d-71825b44a3c0Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-285-04Dye Free Pain RelieverChildrens1 in 1 BOXSUSPENSION17
21130-285-04Dye Free Pain RelieverChildrens118 mL in 1 BOTTLE, PLASTICSUSPENSION1187

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DDYE FREE PAIN RELIEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [SAFEWAY, INC.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DDYE FREE PAIN RELIEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [SAFEWAY, INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDYE FREE PAIN RELIEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [SAFEWAY, INC.]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8DYE FREE PAIN RELIEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [SAFEWAY, INC.]1
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMINACTIVE INGREDIENTK679OBS311DYE FREE PAIN RELIEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [SAFEWAY, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDYE FREE PAIN RELIEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [SAFEWAY, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDYE FREE PAIN RELIEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [SAFEWAY, INC.]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SDYE FREE PAIN RELIEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [SAFEWAY, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DYE FREE PAIN RELIEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [SAFEWAY, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUDYE FREE PAIN RELIEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [SAFEWAY, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RDYE FREE PAIN RELIEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [SAFEWAY, INC.]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4DYE FREE PAIN RELIEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [SAFEWAY, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RDYE FREE PAIN RELIEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [SAFEWAY, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEDYE FREE PAIN RELIEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [SAFEWAY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-285DYE FREE PAIN RELIEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [SAFEWAY, INC.]7Current NDC, Legacy NDC, 2 package rows20241027_7d55cb42-295f-473a-941d-71825b44a3c0.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 77 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sanatos Multi Symptom DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCIPharmadel LLC0ab11691-5b29-55fc-e063-6394a90aa3282023-11-17WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENA-S Medication Solutions1e223faa-f6d0-4235-bc4c-6cfca84a5b0a2023-11-17WarningsExact identifier
application number: M013
SanaTos XACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCIPharmadel LLC85b8ef3d-7318-7f3b-e053-2991aa0a07772023-11-14WarningsExact identifier
application number: M013
RIGHT REMEDIES EXTRA STRENGTH PM Pain ReliefACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.8badbaad-eb35-4251-a779-00474819360d2023-11-13WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENTrifecta Pharmaceuticals USA LLC09935a74-34b0-0e7c-e063-6294a90a7c832023-11-07WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEAMERIFOODS TRADING COMPANYf6dd6396-93e9-1096-e053-6394a90af06d2023-11-02WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENRETAIL BUSINESS SERVICES , LLC.eb644e9e-36dc-5f84-e053-2a95a90affa52023-11-02WarningsExact identifier
application number: M013
Good Sense Childrens Pain and FeverACETAMINOPHENProficient Rx LP46527b1f-7515-44ce-b5cb-9d24223b9af12023-11-01WarningsExact identifier
application number: M013
AspirinASPIRINA-S Medication Solutions12feb32b-4b8c-4b17-9e86-cb286457b0882023-11-01WarningsExact identifier
application number: M013
Acetaminophen, Aspirin, CaffeineACETAMINOPHEN, ASPIRIN, CAFFEINEProficient Rx LPaf8b30a0-7a56-4557-8404-cc8059fcd6bc2023-11-01WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENAMERIFOODS TRADING COMPANYf6dd387d-c768-9443-e053-6394a90aca142023-10-31WarningsExact identifier
application number: M013
ASPIRINASPIRINAMERIFOODS TRADING COMPANYf6cec280-17a5-5c5d-e053-6394a90a81aa2023-10-31WarningsExact identifier
application number: M013
Regular Strength AspirinASPIRINCARDINAL HEALTH, INC.8aaa82c6-b46b-25c5-e053-2a95a90a37932023-10-30WarningsExact identifier
application number: M013
SafeTynadolACETAMINOPHENSinew Pharma Inc.b956d527-7ea7-e084-e053-2a95a90a866d2023-10-28WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEMagno-Humphries, Inc.9d2275c8-0c3d-d2b3-e053-2995a90a368e2023-10-27WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENMagno-Humphries, Inc.9d22bedb-9fb3-8421-e053-2a95a90acf4a2023-10-27WarningsExact identifier
application number: M013
Acetaminophen Regular StrengthACETAMINOPHENMagno-Humphries, Inc.9d22d642-8aaf-d17e-e053-2995a90ae1822023-10-27WarningsExact identifier
application number: M013
ENTERIC COATED ASPIRINASPIRINMagno-Humphries, Inc.a7c02378-4213-4e57-aca2-2437ad02f7862023-10-27WarningsExact identifier
application number: M013
ExtraprinACETAMINOPHEN, ASPIRIN, CAFFEINEMagno-Humphries, Inc.9d22cdc8-29c5-4273-e053-2a95a90ad0bf2023-10-27WarningsExact identifier
application number: M013
Regular Strength Enteric coated aspirinASPIRINGeri-Care Pharmaceutical Corpc321208c-f192-42c5-9454-e0df5d02d6852023-10-26WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN7d55cb42-295f-473a-941d-71825b44a3c07
307668acetaminophen 32 MG/ML Oral SuspensionSCD7d55cb42-295f-473a-941d-71825b44a3c07
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY7d55cb42-295f-473a-941d-71825b44a3c07
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY7d55cb42-295f-473a-941d-71825b44a3c07
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY7d55cb42-295f-473a-941d-71825b44a3c07
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY7d55cb42-295f-473a-941d-71825b44a3c07
307668APAP 32 MG/ML Oral SuspensionSY7d55cb42-295f-473a-941d-71825b44a3c07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
21130-285-04211300285041 BOTTLE, PLASTIC in 1 BOX (21130-285-04) / 118 mL in 1 BOTTLE, PLASTIC2015-06-300000-00-00NoNoCurrent