FDA.reportPublic FDA data

Diphenhydramine Hydrochloride

Product NDC
0904-2056
11-digit product format
009042056
Labeler code
0904
Product ID
0904-2056_4b432cbb-d3d9-2f88-e063-6294a90a7ed5
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-01-02
Marketing end
2027-12-31
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
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
Diphenhydramine Hydrochloride

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1020477Internal RxNorm lookup
1049909Internal RxNorm lookup
1092422Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
04e70311-6412-4a20-84e3-f6e26d5f19abAvailable 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
0904-2056-61Diphenhydramine Hydrochloride10 in 1 BLISTER PACKCAPSULE1017
0904-2056-61Diphenhydramine Hydrochloride10 in 1 BOXCAPSULE1017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-2056-61EA - Each0904-20560fb519f3-b1a4-4405-b123-7e614312896112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]9
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]9
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]9
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]9
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]9
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]9
GELATININACTIVE INGREDIENT2G86QN327LDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]9
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]9
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE HCL CAPSULE [CARDINAL HEALTH]6
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE HCL CAPSULE [CARDINAL HEALTH]6
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDIPHENHYDRAMINE HCL CAPSULE [CARDINAL HEALTH]6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIPHENHYDRAMINE HCL CAPSULE [CARDINAL HEALTH]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADIPHENHYDRAMINE HCL CAPSULE [CARDINAL HEALTH]6
GELATININACTIVE INGREDIENT2G86QN327LDIPHENHYDRAMINE HCL CAPSULE [CARDINAL HEALTH]6
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GDIPHENHYDRAMINE HCL CAPSULE [CARDINAL HEALTH]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIPHENHYDRAMINE HCL CAPSULE [CARDINAL HEALTH]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-2056DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE BANOPHEN (DIPHENHYDRAMINE HCL) CAPSULE [MAJOR PHARMACEUTICALS]15Current NDC, Legacy NDC, 2 package rows20250101_04e70311-6412-4a20-84e3-f6e26d5f19ab.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 54 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunscreen SPF50NON NANO ZINC OXIDESBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESIc5d52f13-a649-9579-e053-2a95a90a062c2026-01-27WarningsExact identifier
application number: M012
XL-3 Night TimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATERnv LLC03210929-331e-462d-b566-4e1865f522462026-01-27WarningsExact identifier
application number: M012
XL-3 Day TimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLRnv LLC2381ff41-4584-4b38-839f-f94e733f5bf22026-01-27WarningsExact identifier
application number: M012
Allergy Relief Extra StrengthDIPHENHYDRAMINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED4f33c1fb-150b-4083-a9a4-c0fbab4b61332026-01-27WarningsExact identifier
application number: M012
Cold and Flu Daytime SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution Inc5ca7dc60-af0c-47c6-b453-8b39c744eb5b2026-01-27WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEHyVee Inc2ce5f2af-cabc-466f-b0c5-256e6e6d4c882026-01-27WarningsExact identifier
application number: M012
Sinus Headache and Pain Day, Non-drowsyACETAMINOPHEN, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICEc33340c0-47d3-45e2-997b-3d9fb148900f2026-01-27WarningsExact identifier
application number: M012
Cold and Flu Daytime SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLL.N.K. International, Inc.b7501b59-d25a-49ec-9cbf-47018bce83972026-01-27WarningsExact identifier
application number: M012
good sense nighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEL. Perrigo Companyf90bd64a-dd1a-4319-87cd-427d57f677ab2026-01-26WarningsExact identifier
application number: M012
Equate Health Non Drowsy DAY Cold and Flu Plus and NIGHTTIME Cold and Flu PlusACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Inc547ff880-3d40-4a4a-84ee-cd0d5290a9b92026-01-26WarningsExact identifier
application number: M012
Maximum Strength Non Drowsy Day and Night Cold and FluMAXIMUM STRENGTH NON DROWSY DAY AND NIGHT COLD AND FLUWAL-MART STORES INCd6a35fb8-1899-4da2-ad2b-0423e332845d2026-01-26WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESINProdose, Inc.7e5de5b0-18f0-4807-8686-da9821f918ce2026-01-26WarningsExact identifier
application number: M012
ALLERGY RELIEFDIPHENHYDRAMINE HYDROCHLORIDEWal-Mart Stores Incb9fbf917-12b7-770f-e053-2995a90afe932026-01-26WarningsExact identifier
application number: M012
Maximum Strength Non Drowsy Daytime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Incb58b2c36-a403-4dae-b3b2-f0ffd28a963b2026-01-26WarningsExact identifier
application number: M012
Allergy Relief Dye FreeDIPHENHYDRAMINE HCLWal-Mart Stores Inc870e6bcb-84ab-45e0-ae57-08a9a182eb0b2026-01-26WarningsExact identifier
application number: M012
Allergy Relief Dye FreeDIPHENHYDRAMINE HCLWal-Mart Stores Inceb8e83a4-981b-48a5-88f4-3a0ba358d3bc2026-01-26WarningsExact identifier
application number: M012
NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Inc8d2d765f-a7e3-40e6-b35d-0e8806a7ea592026-01-26WarningsExact identifier
application number: M012
NIGHTTIME COLD AND FLU CHERRYPHENYLEPHRINE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, DOXYLAMINE SUCCINATEWalgreen Company02a6781c-aa6f-8fb0-e063-6294a90a043d2026-01-26WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN, DOXYLAMINE SUCCINATEWalgreen Company02e5f475-4e9f-2856-e063-6294a90a21fd2026-01-26WarningsExact identifier
application number: M012
GNP Vapor Steam camphor (synthetic)CAMPHOR (SYNTHETIC)AmerisourceBergen0bcc55bf-9654-120b-e063-6394a90a59d12026-01-26WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092422BANOPHEN 25 MG Oral CapsulePSN04e70311-6412-4a20-84e3-f6e26d5f19ab17
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN04e70311-6412-4a20-84e3-f6e26d5f19ab17
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN04e70311-6412-4a20-84e3-f6e26d5f19ab17
1092422diphenhydramine hydrochloride 25 MG Oral Capsule [Banophen]SBD04e70311-6412-4a20-84e3-f6e26d5f19ab17
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD04e70311-6412-4a20-84e3-f6e26d5f19ab17
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD04e70311-6412-4a20-84e3-f6e26d5f19ab17
1092422Banophen 25 MG Oral CapsuleSY04e70311-6412-4a20-84e3-f6e26d5f19ab17
1020477diphenhydramine HCl 50 MG Oral CapsuleSY04e70311-6412-4a20-84e3-f6e26d5f19ab17
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSNabc0e348-8532-4658-bd8c-d7dbe5a28c7d16
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCDabc0e348-8532-4658-bd8c-d7dbe5a28c7d16
1020477diphenhydramine HCl 50 MG Oral CapsuleSYabc0e348-8532-4658-bd8c-d7dbe5a28c7d16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-2056-610090420566110 BLISTER PACK in 1 BOX (0904-2056-61) / 10 CAPSULE in 1 BLISTER PACK10 blister pack2009-01-022027-12-31NoNoCurrent