FDA.reportPublic FDA data

NDC 35916-0709-01 - Acetaminophen , Aspirin and Caffeine

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
35916-0709
Requested NDC
35916-0709-01
Package NDCs from labels
35916-0709-1, 35916-0709-01
Manufacturer
Softgel Healthcare Pvt Ltd
Effective date
2026-04-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Acetaminophen , Aspirin and Caffeine - Softgel Healthcare Pvt LtdSoftgel Healthcare Pvt Ltd2026-04-27HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35916-0709-1Acetaminophen , Aspirin and Caffeine1500 in 1 BAGCAPSULE15002

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 27 of 341 · 6,817 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Relief Aspirin Chewable, Low DoseASPIRINRite Aid Corporation65cdce0f-be04-43ba-8c68-bdce7983cfa12026-06-22WarningsExact identifier
application number: M013
unii: R16CO5Y76E
RYDEEN UV CLEARSUNSCREENGuangzhou Oupeng Cosmetics Co., Ltd.548000cd-1655-aeb3-e063-6294a90ad0042026-06-22WarningsExact identifier
unii: 15FIX9V2JP
Isopropyl Rubbing Alcohol 70ISOPROPYL ALCOHOLDelon Laboratories (1990) Ltd.fb481568-0c51-421f-9b73-adb4c84645aa2026-06-22WarningsExact identifier
unii: ND2M416302
MedlineISOPROPYL ALCOHOLMedline Industries, LP495076e9-3187-6bfa-e063-6394a90a01f52026-06-22WarningsExact identifier
unii: ND2M416302
DAYTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED59db2573-7ebb-4cf9-bfe3-428929bb4eeb2026-06-22WarningsExact identifier
unii: 362O9ITL9D
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEBest Choice (Valu Merchandisers Company)bfec14d5-d9ce-4b9c-a803-3d01cb00b56c2026-06-22WarningsExact identifier
unii: 362O9ITL9D
Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEWinCo Foods, LLC5f1aaa8e-c65f-43b3-9850-c60c1663d78f2026-06-22WarningsExact identifier
unii: 362O9ITL9D
DAY TIME INTENSE FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEMeijer, Inc.e5a64d5a-c1ff-453d-b0c1-fe265b9e2c8a2026-06-22WarningsExact identifier
unii: 362O9ITL9D
ESPOIR BE VELVET COVER CUSHIONHOMOSALATE, TITANIUM DIOXIDEESPOIR Corporation54ce2420-4ac0-eb51-e063-6294a90a2de92026-06-21WarningsExact identifier
unii: 15FIX9V2JP
BABIES KIDSSUN PROTECTIONMINERAL SUNSCREENPANERGYTEK USA INC3a554118-b71d-a844-e063-6294a90a699f2026-06-20WarningsExact identifier
unii: 15FIX9V2JP
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack1c793d37-cbc9-4d76-a84a-d076b51011432026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Aspirin RegimenASPIRINCardinal Health 110, LLC. DBA Leader88f425df-712d-4911-824b-94085c7190b62026-06-19WarningsExact identifier
application number: M013
unii: R16CO5Y76E
Aspirin Low DoseASPIRINMeijer Distribution, Inc.3716a7d4-a555-4e54-aa0a-7b8f3e32addb2026-06-19WarningsExact identifier
application number: M013
unii: R16CO5Y76E
Pain ReliefACETAMINOPHENDOLGENCORP, LLCacc94a3e-21b6-4375-9881-38cf9bab86922026-06-19WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Maximum Strength Multi-Symptom ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBRKROGER COMPANY30d4c4b9-0f5f-0279-e063-6394a90af1b52026-06-19WarningsExact identifier
unii: 362O9ITL9D
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: 3NXW29V3WO
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: 3NXW29V3WO
Aspirin Low DoseASPIRINL.N.K. International, Inc.2f6ec676-3832-420e-be91-fce83f6586c82026-06-19WarningsExact identifier
application number: M013
unii: R16CO5Y76E
equaline nighttime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEUnited Natural Foods, Inc. dba UNFI490766e7-1781-4b2b-a8f4-d4efb9fff5602026-06-19WarningsExact identifier
unii: 362O9ITL9D
Extra Strength TYLENOL Cold plus Flu Multi Symptom DayACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC5487b2e1-b0e5-0236-e063-6394a90a3a8b2026-06-18WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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