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

Additional Listing Data#

Finished product
Yes
Brand name base
Diphenhydramine Hydrochloride

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1049909

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

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