FDA.reportPublic FDA data

Dr Kids

Product NDC
73282-2521
11-digit product format
732822521
Labeler code
73282
Product ID
73282-2521_3fb76edf-2e1e-471b-e063-6294a90aa10f
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
CalmCo LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-20
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
Dr Kids
Brand name suffix
Allergy Relief
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73282-2521-1Dr KidsAllergy Relief24 in 1 POUCHSOLUTION244
73282-2521-2Dr KidsAllergy Relief5 mL in 1 VIAL, SINGLE-DOSESOLUTION54
73282-2521-2Dr KidsAllergy Relief20 in 1 POUCHSOLUTION204
73282-2521-3Dr KidsAllergy Relief30 in 1 POUCHSOLUTION304
73282-2521-4Dr KidsAllergy Relief48 in 1 POUCHSOLUTION484
73282-2521-5Dr KidsAllergy Relief5 mL in 1 VIAL, SINGLE-DOSESOLUTION54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73282-2521DR KIDS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) SOLUTION [CALMCO LLC]2Current NDC, 6 package rows20250223_28ec213e-fabb-28ec-e063-6394a90ad102.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN28ec213e-fabb-28ec-e063-6394a90ad1024
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD28ec213e-fabb-28ec-e063-6394a90ad1024
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY28ec213e-fabb-28ec-e063-6394a90ad1024
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY28ec213e-fabb-28ec-e063-6394a90ad1024
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY28ec213e-fabb-28ec-e063-6394a90ad1024

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73282-2521-17328225210124 VIAL, SINGLE-DOSE in 1 POUCH (73282-2521-1) / 5 mL in 1 VIAL, SINGLE-DOSE (73282-2521-5) 2025-01-20NoNoCurrent
73282-2521-2732822521025 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
73282-2521-37328225210330 VIAL, SINGLE-DOSE in 1 POUCH (73282-2521-3) / 5 mL in 1 VIAL, SINGLE-DOSE (73282-2521-5) 2025-10-01NoNoCurrent
73282-2521-47328225210448 VIAL, SINGLE-DOSE in 1 POUCH (73282-2521-4) / 5 mL in 1 VIAL, SINGLE-DOSE (73282-2521-5) 2025-10-01NoNoCurrent
73282-2521-5732822521055 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical