MAX ALLERGY KIDS

Product NDC
71399-0023
11-digit product format
713990023
Labeler code
71399
Product ID
71399-0023_4228a7ba-b3bb-9957-e063-6394a90a610a
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Akron Pharma Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-11-15
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
MAX ALLERGY KIDS
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71399-0023-42025-03-10C16284748780-12cef2736-91c7-d83d-e063-dadaa90ab31fMAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-42025-03-10C16284748780-12cef2736-91c7-d83d-e063-dadaa90ab31fMAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-62025-03-10C16284748780-12cef2736-91c7-d83d-e063-dadaa90ab31fMAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-62025-03-10C16284748780-12cef2736-91c7-d83d-e063-dadaa90ab31fMAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-82025-03-10C16284748780-12cef2736-91c7-d83d-e063-dadaa90ab31fMAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-82025-03-10C16284748780-12cef2736-91c7-d83d-e063-dadaa90ab31fMAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-42025-01-30C16284748780-12cef2736-91c7-d83d-e063-dadaa90ab31fMAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-42025-01-30C16284748780-12cef2736-91c7-d83d-e063-dadaa90ab31fMAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-62025-01-30C16284748780-12cef2736-91c7-d83d-e063-dadaa90ab31fMAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-62025-01-30C16284748780-12cef2736-91c7-d83d-e063-dadaa90ab31fMAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-82025-01-30C16284748780-12cef2736-91c7-d83d-e063-dadaa90ab31fMAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-82025-01-30C16284748780-12cef2736-91c7-d83d-e063-dadaa90ab31fMAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-0023-4MAX ALLERGY KIDS118 mL in 1 BOTTLESOLUTION1185
71399-0023-6MAX ALLERGY KIDS473 mL in 1 BOTTLESOLUTION4735
71399-0023-8MAX ALLERGY KIDS236 mL in 1 BOTTLESOLUTION2365

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-0023-4ML - Milliliter71399-0023232720a1-d277-4d6a-a8c5-7701426738e612024-08-12
71399-0023-6ML - Milliliter71399-00233429ad22-cb2f-4777-ad75-bd0189be58f712024-08-12
71399-0023-8ML - Milliliter71399-002387e2cddc-3c9a-4e7c-8059-082b6eacd04312024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-0023MAX ALLERGY KIDS (DIPHENHYDRAMINE HCL) SOLUTION [AKRON PHARMA INC.]3Current NDC, 3 package rows20250312_96c4ade8-67b1-41e5-8624-fb49090208af.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN96c4ade8-67b1-41e5-8624-fb49090208af5
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD96c4ade8-67b1-41e5-8624-fb49090208af5
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY96c4ade8-67b1-41e5-8624-fb49090208af5
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY96c4ade8-67b1-41e5-8624-fb49090208af5
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY96c4ade8-67b1-41e5-8624-fb49090208af5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71399-0023-471399002304118 mL in 1 BOTTLE (71399-0023-4) 118 ml2023-11-15NoNoCurrent
71399-0023-671399002306473 mL in 1 BOTTLE (71399-0023-6) 473 ml2023-11-24NoNoCurrent
71399-0023-871399002308236 mL in 1 BOTTLE (71399-0023-8) 236 ml2023-11-15NoNoCurrent