FDA.reportPublic FDA data

Diphenhydramine Hydrochloride

Product NDC
42806-648
11-digit product format
428060648
Labeler code
42806
Product ID
42806-648_92732b8c-9804-4019-bd6c-5cc5077b1b0e
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Epic Pharma, LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-11-22
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
Diphenhydramine Hydrochloride
Listing expiration
2026-12-31

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
a083dec1-d4a7-4573-8a14-f5739d5bf153Available 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
42806-648-10Diphenhydramine Hydrochloride1000 in 1 BOTTLECAPSULE10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-648-10EA - Each42806-648101d637c-4636-4598-9c22-bc9eca653b2b12017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-648DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC]1Current NDC, Legacy NDC, 1 package rows20170401_a083dec1-d4a7-4573-8a14-f5739d5bf153.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEEpic Pharma, LLCa083dec1-d4a7-4573-8a14-f5739d5bf1532016-11-22WarningsExact identifier
ndc (product): 42806-648

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN88f1ac7b-31a1-0636-e053-2a95a90a50012
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD88f1ac7b-31a1-0636-e053-2a95a90a50012
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSNa083dec1-d4a7-4573-8a14-f5739d5bf1531
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCDa083dec1-d4a7-4573-8a14-f5739d5bf1531

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42806-648-10428060648101000 CAPSULE in 1 BOTTLE (42806-648-10) 1000 capsule2016-11-220000-00-00NoNoCurrent