FDA.reportPublic FDA data

Diphenhydramine Hcl

Product NDC
58805-001
11-digit product format
588050001
Labeler code
58805
Product ID
58805-001_108b7ac2-082d-47d4-a07d-58c50e40bb5c
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hcl
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Agile Pharmachem
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-10-15
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58805-001-142020-01-31C16284748780-19d75b9d0-1e4f-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58805-001-14Diphenhydramine Hcl3600 in 1 BLISTER PACKCAPSULE, LIQUID FILLED36001
58805-001-14Diphenhydramine Hcl1 in 1 CARTONCAPSULE, LIQUID FILLED11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]1
GELATININACTIVE INGREDIENT2G86QN327LDIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]1
POLYETHYLENE GLYCOL 1000INACTIVE INGREDIENTU076Q6Q621DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]1
SORBITOLINACTIVE INGREDIENT506T60A25RDIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58805-001DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]1Legacy NDC, 2 package rows20140217_92445b53-cd51-4bc8-9db9-cbc9d3ea9d4c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN92445b53-cd51-4bc8-9db9-cbc9d3ea9d4c1
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD92445b53-cd51-4bc8-9db9-cbc9d3ea9d4c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
58805-001-14588050001143600 in 1 BLISTER PACKHistorical