FDA.reportPublic FDA data

Allergy

Product NDC
56062-923
11-digit product format
560620923
Labeler code
56062
Product ID
56062-923_f16600d1-e885-4659-b316-fd4cdde98455
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Publix Super Markets Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-28
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
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
Allergy
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049630Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f2263e38-f686-45ed-bf85-b47f5e1aa982Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
56062-923-08Allergy12 in 1 BLISTER PACKTABLET, FILM COATED123
56062-923-08Allergy2 in 1 CARTONTABLET, FILM COATED23
56062-923-12Allergy1 in 1 CARTONTABLET, FILM COATED13
56062-923-12Allergy100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56062-923ALLERGY (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [PUBLIX SUPER MARKETS INC]2Current NDC, 4 package rows20250429_f2263e38-f686-45ed-bf85-b47f5e1aa982.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 49 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sinus Pressure, Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company97554f40-f9aa-4dbf-a6f2-de6197236ab42026-02-25WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLFamily Dollar Stores, Inc1b50b865-3dfc-4b3f-86d5-5e91ca7724452026-02-24Warnings, Adverse reactionsExact identifier
application number: M012
VaproizingCAMPHORH E B577fda09-588a-4c2e-ada5-eeda32d1aabe2026-02-24Warnings, Adverse reactionsExact identifier
application number: M012
Sore Throat Logenzes Sore ThroatBENZOCAINE AND MENTHOLMajor Pharmaceuticals11416620-4892-44ba-9780-db27efff67432026-02-24WarningsExact identifier
application number: M012
Family Wellness SF Honey Lemon Cough DropsMENTHOLFamily Dollar4437853d-1f42-a41d-e063-6294a90aa81e2026-02-24WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEBest Choice (Valu Merchandisers Company)64a93715-e7b1-4de1-8099-8ad6c585d5172026-02-24WarningsExact identifier
application number: M012
Cough and Chest Congestion DM DaytimeDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED86af74c2-9183-4ee9-ad1e-d88dfc8bf47d2026-02-24WarningsExact identifier
application number: M012
Cough DM NighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED39adf23e-76f3-42e1-a9f4-55feb38078e52026-02-24WarningsExact identifier
application number: M012
Revasol Tussin DM Cough Suppressant ExpectorantDEXTROMETHORPHAN HBR, GUAIFENESINRnv LLC4b7fd320-2f39-fa1a-e063-6294a90ada9e2026-02-23WarningsExact identifier
application number: M012
Dimetapp Cold and AllergyBROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDEFoundation Consumer Brands47317865-4310-4f07-8815-f3130963307d2026-02-23WarningsExact identifier
application number: M012
Dimetapp Cold and Cough and Dimetapp Nighttime Cold and CongestionBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DIPHENHYDRAMINE HYRDOCHLORIDEFoundation Consumer Brands42720fa0-fcdd-4614-80b2-16d0ada345b12026-02-23WarningsExact identifier
application number: M012
Dimetapp Cold and CoughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEFoundation Consumer Brandscc09a8c5-d173-4261-b838-96e6a16e2ff92026-02-23WarningsExact identifier
application number: M012
Dimetapp Nighttime Cold and CongestionDIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDEFoundation Consumer Brands96a1055f-e831-4f4b-8af3-7a41838c194c2026-02-23WarningsExact identifier
application number: M012
Dimetapp Cold and Cough and Nighttime Cold and CongestionDIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDEFoundation Consumer Brands1fbe1ce0-5e3e-4af5-a5f1-85ed12ced2462026-02-23WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLBetter Living Brands, LLC0948648c-1c5f-4225-a754-120ca8859f192026-02-23Warnings, Adverse reactionsExact identifier
application number: M012
Revasol TussinGUAIFENESINRnv LLCf66dc593-9023-40e8-9cc3-0380b04b43052026-02-23WarningsExact identifier
application number: M012
Equate VaporizingCAMPHOR, EUCALYPTUS OIL, MENTHOLWal-Mart Stores Inc3006971b-784c-43fd-91a6-d96876bbf1852026-02-23WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEMajor Pharmaceuticals04e70311-6412-4a20-84e3-f6e26d5f19ab2026-02-20WarningsExact identifier
application number: M012
BanophenDIPHENHYDRAMINE HCLMajor Pharmaceuticals7f2b72cc-d4f7-431f-be61-c103cf8c489e2026-02-20WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEMajor Pharmaceuticalsdca04d80-e781-40b1-e053-2995a90a70102026-02-20WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNf2263e38-f686-45ed-bf85-b47f5e1aa9823
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDf2263e38-f686-45ed-bf85-b47f5e1aa9823

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
56062-923-08560620923082 BLISTER PACK in 1 CARTON (56062-923-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2025-04-28NoNoCurrent
56062-923-12560620923121 BOTTLE, PLASTIC in 1 CARTON (56062-923-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2025-04-28NoNoCurrent