FDA.reportPublic FDA data

Diphenhydramine HCl Oral Solution

Product NDC
69339-152
11-digit product format
693390152
Labeler code
69339
Product ID
69339-152_6c998d25-3573-4c6b-822a-1c16eeddd642
Type
HUMAN OTC DRUG
Nonproprietary name
diphenhydramine hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Natco Pharma USA LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-12-14
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/10mL
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 HCl Oral Solution
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1049906

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
69339-152-01Diphenhydramine HCl Oral Solution10 mL in 1 CUP, UNIT-DOSESOLUTION106
69339-152-17Diphenhydramine HCl Oral Solution4 in 1 CASESOLUTION46
69339-152-17Diphenhydramine HCl Oral Solution10 in 1 TRAYSOLUTION106
69339-152-19Diphenhydramine HCl Oral Solution10 in 1 CASESOLUTION106
69339-152-19Diphenhydramine HCl Oral Solution10 in 1 TRAYSOLUTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69339-152-01ML - Milliliter69339-152647442f3-f072-4ea8-b0e3-43cbbc52d60912021-01-08
69339-152-17ML - Milliliter69339-152b053be9b-804f-4cfe-b7b9-6cfde7ecb26f12021-01-08
69339-152-19ML - Milliliter69339-152da851f3d-9a4a-431d-9e74-005b6279e35412021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69339-152DIPHENHYDRAMINE HCL ORAL SOLUTION (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [NATCO PHARMA USA LLC]6Current NDC, Legacy NDC, 5 package rows20231102_54b64354-ac10-42ff-a53d-96cef933a91a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN54b64354-ac10-42ff-a53d-96cef933a91a6
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD54b64354-ac10-42ff-a53d-96cef933a91a6
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY54b64354-ac10-42ff-a53d-96cef933a91a6
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY54b64354-ac10-42ff-a53d-96cef933a91a6
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY54b64354-ac10-42ff-a53d-96cef933a91a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69339-152-016933901520110 mL in 1 CUP, UNIT-DOSE10 mlHistorical
69339-152-17693390152174 TRAY in 1 CASE (69339-152-17) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (69339-152-01) 4 tray2020-12-140000-00-00NoNoCurrent
69339-152-196933901521910 TRAY in 1 CASE (69339-152-19) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (69339-152-01) 10 tray2020-12-140000-00-00NoNoCurrent