FDA.reportPublic FDA data

NDC 64380-732-19 - IBUPROFEN AND DIPHENHYDRAMINE HCL

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
64380-732
Requested NDC
64380-732-19
Package NDCs from labels
64380-732-14, 64380-732-15, 64380-732-19, 64380-732-20, 64380-732-29, 64380-732-12, 64380-732-13, 64380-732-11, 64380-732-18, 64380-732-92
Manufacturer
Strides Pharma Science Limited
Effective date
2022-02-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
IBUPROFEN AND DIPHENHYDRAMINE HCL - Strides Pharma Science LimitedStrides Pharma Science Limited2022-02-08HUMAN OTC DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40IBUPROFEN AND DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]2
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN AND DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MIBUPROFEN AND DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]2
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN AND DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3IBUPROFEN AND DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LIBUPROFEN AND DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDIBUPROFEN AND DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]2
GELATININACTIVE INGREDIENT2G86QN327LIBUPROFEN AND DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]2
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62IBUPROFEN AND DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]2
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UIBUPROFEN AND DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]2
POLYETHYLENE GLYCOL 600INACTIVE INGREDIENTNL4J9F21N9IBUPROFEN AND DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TIBUPROFEN AND DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]2
SHELLACINACTIVE INGREDIENT46N107B71OIBUPROFEN AND DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]2
SORBITANINACTIVE INGREDIENT6O92ICV9RUIBUPROFEN AND DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]2
SORBITOLINACTIVE INGREDIENT506T60A25RIBUPROFEN AND DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN AND DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]2
WATERINACTIVE INGREDIENT059QF0KO0RIBUPROFEN AND DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]2

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 1 of 118 · 2,345 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime Sleep Aid Berry FlavorDIPHENHYDRAMINE HYDROCHLORIDERaritan Pharmaceuticals Inc303d7651-9c8f-4a14-9f2c-7181fa0f003e2026-09-09WarningsExact identifier
unii: TC2D6JAD40
dual actionACETAMINOPHEN, IBUPROFENRite Aid Corporation54b08d24-d5e9-4111-9d97-329896e8309d2026-09-09WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENLidl US LLC0ca02f8b-4413-4e7c-a67b-8c67c53e13432026-09-09WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENGOODSENSE596a1007-08ea-00ec-e063-6394a90a5eb22026-09-09WarningsExact identifier
unii: WK2XYI10QM
ibuprofen childrensIBUPROFENRite Aid Corporationc6e68886-edcb-414d-9cba-0d97772ef8b62026-09-09WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen minisIBUPROFENThe Kroger Co.15709fa7-114b-453c-b63d-f1c4f28f0f952026-09-08WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENREMEDYREPACK INC.2144eff0-d7ab-486d-b116-a4ff3ae2afe22026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
VICKS ZzzQuil NIGHTTIME SLEEP-AID Diphenhydramine HCl FREE OFDIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Company01906eed-78ee-f2a1-e063-6294a90a809b2026-09-08WarningsExact identifier
unii: TC2D6JAD40
Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINERARITAN PHARMACEUTICALS INC9819155b-2713-42be-867e-16605e7643d02026-09-08WarningsExact identifier
unii: TC2D6JAD40
IbuprofenIBUPROFENThe Kroger Co.a7789f7f-3356-463b-9fd7-2d7f7eba27992026-09-08WarningsExact identifier
unii: WK2XYI10QM
Drx Choice childrens allergy chewsDIPHENHYDRAMINE HCLRARITAN PHARMACEUTICALS INCdd2be906-bd0a-437c-9693-54b9391a5da32026-09-05WarningsExact identifier
unii: TC2D6JAD40
IBUPROFENIBUPROFENAmazon.com Services LLC90659e83-d989-46a5-9680-3a4f616125112026-09-04WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENDirect_Rx40071818-5bf0-095b-e063-6294a90ad58a2026-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENChain Drug Marketing Association, Inc.8d518a08-486a-4d11-b042-27fc1e6060c92026-09-03WarningsExact identifier
unii: WK2XYI10QM
IBUPROFEN Immediate ReleaseIBUPROFENStrides Pharma Inca5dd275f-f388-44ec-8297-74430a742d522026-09-02Boxed warning, WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.0fa4cd66-66ad-4ec9-b38c-6b5840df39df2026-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINEKROGER COMPANY7def6781-0881-46bf-ad7a-7a3f23a8d9f72026-09-02WarningsExact identifier
unii: TC2D6JAD40
Ibuprofen Immediate ReleaseIBUPROFENStrides Pharma Incebcc4da3-d0f6-4e40-99b5-e88310ea4a5b2026-09-02Boxed warning, WarningsExact identifier
unii: WK2XYI10QM
Sleep AidDIPHENHYDRAMINE HCLTARGET Corporationedfe32b5-9213-4350-9508-2530ee26c5d52026-09-02WarningsExact identifier
unii: TC2D6JAD40
Maximum Strength Nighttime Cold and FluACETAMINOPHEN , DIPHENHYDRAMINE HCL,PHENYLEPHRINE HCLTHE KROGER CO058b2021-8a61-40b0-8a2e-a784d2b847fb2026-09-02WarningsExact identifier
unii: TC2D6JAD40

Reported adverse events (FAERS/openFDA)#

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