FDA.reportPublic FDA data

Diphenhydramine HCl

Product NDC
60687-829
11-digit product format
606870829
Labeler code
60687
Product ID
60687-829_1d639138-d6a9-588b-e063-6394a90a2bb9
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
American Health Packaging
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-08-04
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
12.5 mg/5mL
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg/5mL

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
60687-829-40Diphenhydramine HCl5 mL in 1 CUP, UNIT-DOSESOLUTION51
60687-829-46Diphenhydramine HCl10 in 1 TRAYSOLUTION101
60687-829-86Diphenhydramine HCl10 in 1 CASESOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-829-40ML - Milliliter60687-8294229f2cb-2587-4f47-977d-9101e08eaefa12024-08-12
60687-829-86ML - Milliliter60687-829b1a76687-7b8c-4093-b22a-a673a2357bcb12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-829DIPHENHYDRAMINE HCL (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [AMERICAN HEALTH PACKAGING]1Current NDC, 3 package rows20240807_4cd8aee3-5522-434b-a1b1-9591bed3e9a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN4cd8aee3-5522-434b-a1b1-9591bed3e9a61
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD4cd8aee3-5522-434b-a1b1-9591bed3e9a61
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY4cd8aee3-5522-434b-a1b1-9591bed3e9a61
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY4cd8aee3-5522-434b-a1b1-9591bed3e9a61
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY4cd8aee3-5522-434b-a1b1-9591bed3e9a61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-829-40606870829405 mL in 1 CUP, UNIT-DOSE5 mlHistorical
60687-829-466068708294610 in 1 TRAYHistorical
60687-829-866068708298610 TRAY in 1 CASE (60687-829-86) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-829-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-829-40) 10 tray2024-08-04NoNoCurrent