FDA.reportPublic FDA data

DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML

Product NDC
82568-0016
11-digit product format
825680016
Labeler code
82568
Product ID
82568-0016_3404aa22-166f-5501-e063-6394a90a1e7a
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML
Dosage form
SOLUTION
Route
ORAL
Labeler
AARNA USA INC.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-14
Substance
DIPHENHYDRAMINE
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 12.5 MG PER 5 ML
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE12.5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8GTS82S83M
Rxcui1049906

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82568-0016-4DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML118 mL in 1 BOTTLESOLUTION1183
82568-0016-6DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML473 mL in 1 BOTTLESOLUTION4733
82568-0016-8DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML236 mL in 1 BOTTLESOLUTION2363

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82568-0016-4ML - Milliliter82568-001635c7c353-2342-4500-98d2-2480ea09f79e12025-06-13
82568-0016-6ML - Milliliter82568-00166b0be2fa-03eb-4541-af14-49f9b301ad0712025-06-13
82568-0016-8ML - Milliliter82568-001670c09490-6b01-4c56-9ed5-6cdc7beb09ee12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82568-0016DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML SOLUTION [AARNA USA INC.]3Current NDC, 3 package rows20250502_32c26835-f54e-d7e5-e063-6294a90ae1c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN32c26835-f54e-d7e5-e063-6294a90ae1c03
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD32c26835-f54e-d7e5-e063-6294a90ae1c03
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY32c26835-f54e-d7e5-e063-6294a90ae1c03
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY32c26835-f54e-d7e5-e063-6294a90ae1c03
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY32c26835-f54e-d7e5-e063-6294a90ae1c03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82568-0016-482568001604118 mL in 1 BOTTLE (82568-0016-4) 118 ml2025-04-14NoNoHistorical
82568-0016-682568001606473 mL in 1 BOTTLE (82568-0016-6) 473 ml2025-04-14NoNoHistorical
82568-0016-882568001608236 mL in 1 BOTTLE (82568-0016-8) 236 ml2025-04-14NoNoHistorical