Dormin

Product NDC
52412-100
11-digit product format
524120100
Labeler code
52412
Product ID
52412-100_bf433db9-4fdc-4f84-8d34-3c85ec1465bf
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Randob Labs,Ltd.
Application
part338
Marketing category
OTC MONOGRAPH FINAL
Marketing start
1992-01-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dormin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1049909, 1919073

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
52412-100-02Dormin2 in 1 POUCHCAPSULE22
52412-100-32Dormin32 in 1 BOTTLE, PLASTICCAPSULE322
52412-100-72Dormin72 in 1 BOTTLE, PLASTICCAPSULE722

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52412-100DORMIN (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [RANDOB LABS,LTD.]2Current NDC, Legacy NDC, 3 package rows20190416_a23b5195-518e-4093-aea4-10ce96460ee2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSNa23b5195-518e-4093-aea4-10ce96460ee22
1919073Dormin 25 MG Oral CapsulePSNa23b5195-518e-4093-aea4-10ce96460ee22
1919073diphenhydramine hydrochloride 25 MG Oral Capsule [Dormin]SBDa23b5195-518e-4093-aea4-10ce96460ee22
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCDa23b5195-518e-4093-aea4-10ce96460ee22
1919073Dormin 25 MG Oral CapsuleSYa23b5195-518e-4093-aea4-10ce96460ee22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52412-100-02524120100022 CAPSULE in 1 POUCH (52412-100-02) 2 capsule2016-03-010000-00-00NoNoCurrent
52412-100-325241201003232 CAPSULE in 1 BOTTLE, PLASTIC (52412-100-32) 32 capsule1992-01-010000-00-00NoNoCurrent
52412-100-725241201007272 CAPSULE in 1 BOTTLE, PLASTIC (52412-100-72) 72 capsule1992-01-010000-00-00NoNoCurrent