FDA.reportPublic FDA data

NDC 82652-031 - Diphen

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
82652-031
Package NDCs from labels
82652-031-01
Manufacturer
Remedy Pack LLC | Safetec of America, Inc | Allegiant Health | LNK International Inc. | Granules India Limited | Ohm Laboratories
Effective date
2022-07-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DiphenRemedy Pack LLC | Safetec of America, Inc | Allegiant Health | LNK International Inc. | Granules India Limited | Ohm Laboratories2022-07-11HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82652-031-01Diphen1 in 1 PACKETTABLET, FILM COATED425 mg1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82652-031DIPHEN (BENZOCAINE, BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE, HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, CALCIUM CARBONATE, IBUPROFEN, LORATADINE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM OXIDE, MECLIZINE HYDROCHLORIDE, AND BISMUTH SUBSALICYLATE) KIT [REMEDY PACK LLC]1Unmatched20220717_5d185f23-8af6-4e36-b514-5662986520a5.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 175 of 1094 · 21,880 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FixMySkin Healing Balm Vanilla FlavorHYDROCORTISONELovely Skin, Inc.52f7a561-a0b5-4562-a588-d74fd874b83a2026-04-28WarningsExact identifier
application number: M017
B-Pure Moisturizing Hand Sanitizer Vanilla Creme ScentedALCOHOLFourstar Group USA, Inc.13faded0-7953-4d86-b952-e4bcf4ba53cc2026-04-28WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer Sweet Plum and Jasmine ScentedALCOHOLFourstar Group USA, Inc.450d025a-cc11-796e-e063-6394a90a7e5c2026-04-28WarningsExact identifier
unii: 3K9958V90M
B-Pure Hand Sanitizer Coconut Vanilla ScentedALCOHOLFourstar Group USA, Inc.e179b21d-fb93-4671-87c0-b8ae094533282026-04-28WarningsExact identifier
unii: 3K9958V90M
ALKA SELTZER COLD Cold Flu and Congestion Severe Fast DissolveCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.dd7da15a-4e0b-405f-e053-2995a90a06d22026-04-28WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
Anything SPFOCTINOXATE, OCTISALATE, ZINC OXIDE, AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDEAnything SPF LLC508b8dcb-6600-6dad-e063-6294a90a565a2026-04-28WarningsExact identifier
unii: 15FIX9V2JP
CAREONE CHILDRENS COLD COUGHBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDERetail Business Services, LLC382f7d51-ceb8-4bdf-9bd5-440b50c65cd32026-04-28WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
SCOTT Antimicrobial Foam Skin CleanserBENZALKONIUM CHLORIDEKimberly-Clark210f7da3-63c5-4a4b-8db0-8d6d1663751d2026-04-28WarningsExact identifier
application number: M003
unii: F5UM2KM3W7
PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDECaplin Steriles Limited1b9f1d54-ea46-49c8-a33e-c94a61bc04602026-04-28Warnings, Adverse reactionsExact identifier
unii: 04JA59TNSJ
Sleep AidDIPHENHYDRAMINE HCLWalgreen Companyf8f17615-e4ec-49d4-9c0d-581d0fd6feb72026-04-28WarningsExact identifier
unii: TC2D6JAD40
FolyraMULTIVITAMINOncora Pharma, LLCcb182e26-17c5-4d00-869f-08823afeeee82026-04-28Warnings, Adverse reactionsExact identifier
unii: H0G9379FGK
unii: 3A3U0GI71G
Nighttime Sleep AidDIPHENHYDRAMINE HCLL.N.K. International, Inc.888dc258-d5a3-4b62-aea1-c81ea29ff6f52026-04-28WarningsExact identifier
unii: TC2D6JAD40
Cold and Flu Daytime ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLL.N.K. International, Inc.1a520b4f-6a4b-4e37-94c5-9387f2e4c34a2026-04-27WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
Calcium CarbonateCALCIUM CARBONATECardinal Health 107, LLC8109dd2b-875c-40eb-82ac-d3780bc0c4372026-04-27WarningsExact identifier
application number: M001
unii: H0G9379FGK
Childrens Multi-Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEKroger49a7cd2a-8c0e-2196-e063-6294a90a134a2026-04-27WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 495W7451VQ
Sleep AidDIPHENHYDRAMINE HCLAmerisource Bergen8f1cb631-4633-4ef5-868e-48a46ab311a42026-04-27WarningsExact identifier
unii: TC2D6JAD40
Blue Star MedicatedCAMPHORFocus Consumer Healthcare, LLC56df008e-a23b-4870-e054-00144ff8d46c2026-04-27WarningsExact identifier
application number: M017
Guaifenesin,Dextromethorphan HbrGUAIFENESIN,DEXTROMETHORPHAN HBRSoftgel Healthcare Pvt Ltd3e5d978f-cc70-60a5-e063-6394a90a67d32026-04-27WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 495W7451VQ
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDESoftgel Healthcare Pvt Ltd36ced59c-12dc-441f-e063-6294a90a32392026-04-27WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mgACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCLSoftgel Healthcare Private Limited30ab39f3-27cc-5728-e063-6394a90a9cbe2026-04-27WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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