FDA.reportPublic FDA data

Diphenhydramine Hydrochloride

Product NDC
0904-7237
11-digit product format
009047237
Labeler code
0904
Product ID
0904-7237_4b433ad6-a0bd-3f85-e063-6394a90a0785
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
2022-04-14
Marketing end
2028-04-30
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 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 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
1049909Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dca04d80-e781-40b1-e053-2995a90a7010Available 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
0904-7237-24Diphenhydramine Hydrochloride2 in 1 CARTONCAPSULE24
0904-7237-24Diphenhydramine Hydrochloride12 in 1 BLISTER PACKCAPSULE124
0904-7237-60Diphenhydramine Hydrochloride100 in 1 BOTTLECAPSULE1004
0904-7237-61Diphenhydramine Hydrochloride10 in 1 BOX, UNIT-DOSECAPSULE104
0904-7237-61Diphenhydramine Hydrochloride10 in 1 BLISTER PACKCAPSULE104
0904-7237-80Diphenhydramine Hydrochloride1000 in 1 BOTTLECAPSULE10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7237-24EA - Each0904-72370f407112-e93a-4544-a880-485bfe00249e12022-11-07
0904-7237-60EA - Each0904-72370ee1a165-13f2-4f89-b39c-1c8f9e940d2812022-10-06
0904-7237-61EA - Each0904-72379d1b9365-5c30-45de-8071-c9a0262ad0c812023-01-09
0904-7237-80EA - Each0904-7237a9264169-ed21-468e-860b-7bb8a0f8406212022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7237DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]2Current NDC, Legacy NDC, 6 package rows20241208_dca04d80-e781-40b1-e053-2995a90a7010.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 4 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WALMART DAYTIME AND NIGHTTIME MS SEVERE RELIEF VALUE PACKACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCLWAL-MART STORES INC888bd90a-a059-4814-bd65-6b735ecfaf3a2026-08-31WarningsExact identifier
application number: M012
Severe Cold and Flu Daytime and NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLKroger49a98411-aa5a-6de3-e063-6294a90a148f2026-08-31WarningsExact identifier
application number: M012
equate daytime nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESEN, PHENYLEPHRINE HYDROCHLORIDESixarp, LLC5a5a6917-9fb5-e6ca-e063-6394a90af9dc2026-08-31WarningsExact identifier
application number: M012
Zicam Intense Sinus ReliefOXYMETAZOLINE HYDROCHLORIDEChurch & Dwight Co., Inc.d916f7ff-84b7-57ef-e053-2995a90a3efa2026-08-31WarningsExact identifier
application number: M012
Afrin Original NasalOXYMETAZOLINE HYDROCHLORIDEJC World Bell Wholesale Co., Inc.ecfa14b8-a3f3-4569-b489-c9e1a51cf09e2026-08-31WarningsExact identifier
application number: M012
Dextromethorphan HBrDEXTROMETHORPHAN HBRBIONPHARMA INC.5a5dde85-8785-8149-e063-6294a90a4d572026-08-31WarningsExact identifier
application number: M012
Equate NasalOXYMETAZOLINE HCLSixarp, LLC5a5e2458-bab0-4931-e063-6394a90ad6062026-08-31WarningsExact identifier
application number: M012
MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH RELIEFDEXTROMETHORPHAN HYDROBROMIDE AND HEXYLRESORCINOLReckitt Benckiser LLC8d670d91-9e22-45b9-b568-5b62c2133d322026-08-31WarningsExact identifier
application number: M012
Daytime Cold and Flu Multi Symptom ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corpe85b4c2a-d4e0-452c-9a08-fcc0ff6eaa212026-08-31WarningsExact identifier
application number: M012
Daytime Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corp67849e09-2056-4013-98b1-d003ed3250a22026-08-31WarningsExact identifier
application number: M012
MAX Tussin Mucus and Chest Congestion Sugar FreeGUAIFENESINAkron Pharma Inc.3b023b91-e703-4599-9864-96d8c328b45c2026-08-31WarningsExact identifier
application number: M012
MAX Tussin Mucus and Chest CongestionGUAIFENESINAkron Pharma Inc.ac874a31-5556-4669-937f-dcb52aaecd8a2026-08-31WarningsExact identifier
application number: M012
MAX Tussin Cough and Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINAkron Pharma Inc.e0ce4287-bfa1-4413-97c8-4fe2e39bda362026-08-31WarningsExact identifier
application number: M012
Acetaminophen PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFI24173e77-92ec-4a87-a471-d6867837c1802026-08-31WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLDOLGENCORP, LLC69af44c2-390c-4223-889a-d5555aef57782026-08-28WarningsExact identifier
application number: M012
Tussin DM DaytimeDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED432d4833-2eaf-4f7c-b6b4-41043a6b7e2a2026-08-28WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLYour Military Exchanges13fcc43c-bdda-4b65-b6d7-23b39e6836512026-08-28Warnings, Adverse reactionsExact identifier
application number: M012
Multi-Symptom AllergyACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLWalgreen Company5170c450-989d-44fa-ab38-86c78feae3b62026-08-28WarningsExact identifier
application number: M012
Pain Reliever PM Extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreens54cbbc5f-908b-47b2-b37f-3646354d35682026-08-27WarningsExact identifier
application number: M012
Maximum Strength Mucus ReliefDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLHyvee Inc4e578c7a-88d4-e4cd-e063-6394a90aac442026-08-27WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSNf40bfdfc-1cb4-4604-9790-fb8d1d5173c6102
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCDf40bfdfc-1cb4-4604-9790-fb8d1d5173c6102
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN5a5c5f33-5b70-465d-a38b-6f518af097887
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD5a5c5f33-5b70-465d-a38b-6f518af097887
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN879a7804-f3d4-4a3d-bc92-b473499d6c956
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD879a7804-f3d4-4a3d-bc92-b473499d6c956
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSNdca04d80-e781-40b1-e053-2995a90a70104
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCDdca04d80-e781-40b1-e053-2995a90a70104
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN5f2b16f0-c58b-4e48-ad92-eaab93c6c4b23
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN0140747e-e674-a4a8-e063-6294a90a1e5a3
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD5f2b16f0-c58b-4e48-ad92-eaab93c6c4b23
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD0140747e-e674-a4a8-e063-6294a90a1e5a3
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN25034563-6422-daf6-e063-6394a90af9801
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN9382c976-3067-4923-a38f-101d1c481e971
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN0ccbc301-6833-bbc4-e063-6294a90aad921
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD9382c976-3067-4923-a38f-101d1c481e971
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD25034563-6422-daf6-e063-6394a90af9801
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD0ccbc301-6833-bbc4-e063-6294a90aad921

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7237-24009047237242 BLISTER PACK in 1 CARTON (0904-7237-24) / 12 CAPSULE in 1 BLISTER PACK2 blister pack2022-04-142028-01-31NoNoCurrent
0904-7237-6000904723760100 CAPSULE in 1 BOTTLE (0904-7237-60) 100 capsule2022-04-142028-02-29NoNoCurrent
0904-7237-610090472376110 BLISTER PACK in 1 BOX, UNIT-DOSE (0904-7237-61) / 10 CAPSULE in 1 BLISTER PACK10 blister pack2022-04-142028-02-29NoNoCurrent
0904-7237-80009047237801000 CAPSULE in 1 BOTTLE (0904-7237-80) 1000 capsule2022-04-142028-04-30NoNoCurrent