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 74 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LOW DOSE ASPIRINASPIRINBryant Ranch Prepack64c28b38-23bb-4c7e-9c19-1d1f0d5975282024-01-18WarningsExact identifier
application number: M013
BuscapinaACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEOPMX LLCe0dd4c04-6811-38a1-e053-2995a90aa3c92024-01-17WarningsExact identifier
application number: M013
Regular Strength AcetaminophenACETAMINOPHENCARDINAL HEALTHbdf8c511-ce25-0e30-e053-2a95a90a33f62024-01-10WarningsExact identifier
application number: M013
Extra Strength Acetaminophen PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANY2560126e-a54a-4a47-9631-a1bca42f52772024-01-10WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINA-S Medication Solutionsee4451c9-4d0f-4373-8f64-fcc1f9dd58562024-01-05WarningsExact identifier
application number: M013
PharbetolACETAMINOPHENProficient Rx LP51ba690e-d76b-41c6-a083-8bc803e1faa22024-01-01WarningsExact identifier
application number: M013
MEDI-FIRST Non-Aspirin Extra StrengthACETAMINOPHENProficient Rx LP9071b047-5463-4f65-b775-bfb0ce0665272024-01-01WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINTIME CAP LABORATORIES, INC1acc8c1a-c746-4635-800c-de1ad758fce02023-12-30WarningsExact identifier
application number: M013
MAX Cold, Flu, and Sore ThroatACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN , PHENYLEPHRINE HCLH E B9b09b660-0758-48dc-84c9-26cdd2aacc032023-12-29WarningsExact identifier
application number: M013
NIGHT-TIME MULTI-SYMPTOM COLD/FLU OriginalACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEDeMoulas Market Basketeb24323f-82a1-4ba3-9359-fe81571c3fba2023-12-29WarningsExact identifier
application number: M013
Nite-TimeCOLD/FLU CHERRY COLD/FLU CHERRYACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESalado Sales, Inc.e6c3e545-b2ad-47f0-8318-c134a8e24f5b2023-12-29WarningsExact identifier
application number: M013
Daytime Non-Drowsy COLD/FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDESalado Sales, Inc.e181b371-78c7-4163-865d-acc064be33ca2023-12-29WarningsExact identifier
application number: M013
Childrens Pain and Fever Cherry flavorACETAMINOPHENWalgreen Company64c65244-f7a3-401b-b83a-bf66d45268e22023-12-29WarningsExact identifier
application number: M013
Nite-Time COLD/FLU ORIGINALACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESalado Sales, Inc.fcd24753-b42b-4d05-8379-0ec0351ab2172023-12-29WarningsExact identifier
application number: M013
NIGHT-TIME MULTI-SYMPTOM COLD/FLU CherryACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEDeMoulas Market Baskete772cdf5-d01d-4752-8cfb-7e7f4d7a8dd02023-12-29WarningsExact identifier
application number: M013
Childrens Pain and Fever, Grape flavorACETAMINOPHENWalgreen Company0995d69f-61aa-40b0-b095-bb8595caf7732023-12-29WarningsExact identifier
application number: M013
DAY-TIME Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDeMoulas Market Basketce900e42-d0c8-408d-a1c3-3a9bef1c97ee2023-12-29WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HCLDOLGENCORP, INC.06553550-5685-f3c3-e063-6394a90aef072023-12-22WarningsExact identifier
application number: M013
Tension Headache Pain Relieving AidACETAMINOPHEN,CAFFEINEWAL-MART STORES INC00fadd26-a6eb-dc5e-e063-6394a90a3cca2023-12-15WarningsExact identifier
application number: M013
Dye-Free Aspirin 81ASPIRINWALGREENSd71a9d3a-cd28-14a8-e053-2995a90a832b2023-12-15WarningsExact 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