FDA.reportPublic FDA data

MAX ALLERGY KIDS

Product NDC
71399-0023
Requested package NDC
71399-0023-6
11-digit product format
713990023
Labeler code
71399
Product ID
71399-0023_5a655a7d-cae6-93d8-e063-6394a90a1cca
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
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
MAX ALLERGY KIDS
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049906Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
96c4ade8-67b1-41e5-8624-fb49090208afAvailable on FDA.report

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, Related label table
NDCEffectiveRelated label
71399-0023-42025-03-10MAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-42025-03-10MAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-42025-03-10MAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-62025-03-10MAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-62025-03-10MAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-62025-03-10MAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-82025-03-10MAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-82025-03-10MAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-82025-03-10MAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-42025-01-30MAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-42025-01-30MAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-42025-01-30MAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-62025-01-30MAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-62025-01-30MAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-62025-01-30MAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-82025-01-30MAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-82025-01-30MAX Allergy Kids Childrens Allergy Antihistamine Diphenhydramine Hydrochloride 12.5mg/5ml Orol Solution DYE-FREE
71399-0023-82025-01-30MAX 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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 190 · 3,793 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLTALIN-DMACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEFORTUNE PHARMACAL COMPANY LIMITED33e1bec0-323b-40b7-809a-cb65a71ad0ce2026-09-17WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRGeiss, Destin & Dunn Inc.1ea07a01-8779-48c2-a287-b7be866cce7b2026-09-10WarningsExact identifier
application number: M012
Childrens Cold and Allergy ReliefBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLStrategic Sourcing Services LLCd64fe757-9948-4727-b5dd-1f8e4e4763e22026-09-10WarningsExact identifier
application number: M012
Cold and Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATEKroger Companyfd41e4a4-330f-4409-8ba3-0b3bb6f45bca2026-09-10WarningsExact identifier
application number: M012
Nighttime Sleep Aid Berry FlavorDIPHENHYDRAMINE HYDROCHLORIDERaritan Pharmaceuticals Inc303d7651-9c8f-4a14-9f2c-7181fa0f003e2026-09-09WarningsExact identifier
application number: M012
DRx Choice Fruit PunchGUAIFENESINRaritan Pharmaceuticals Inca19d7e1c-c04e-41c6-8af6-ecde962992162026-09-09WarningsExact identifier
application number: M012
Mucus Relief Cold Flu and Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc2cb3e17f-3858-4773-a53f-0860ae6ff1b92026-09-09WarningsExact identifier
application number: M012
MUCINEX FAST-MAX Liquid Gels Day Night Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEReckitt Benckiser LLC3856c1e4-814f-85c4-e063-6394a90ab8a82026-09-09WarningsExact identifier
application number: M012
DRx Choice Long Acting CoughDEXTROMETHORPHAN HBRRARITAN PHARMACEUTICALS875b40bd-7955-4048-abbf-7f43d9ea3ac52026-09-09WarningsExact identifier
application number: M012
severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDERite Aid Corporation4b8ae971-ab57-4937-a878-72d905d7b8492026-09-09WarningsExact identifier
application number: M012
Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER 7000082ba9a73-60ef-49fd-960f-5ca2bb79555e2026-09-09WarningsExact identifier
application number: M012
Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE GUAIFENESINThe Kroger Co.49829083-5c0a-4620-bfb3-7103642368db2026-09-09WarningsExact identifier
application number: M012
DRx Choice Childrens Stuffy Nose and Chest CongestionGUAIFENESIN AND PHENYLEPHRINE HCLRARITAN PHARMACEUTICALS7a3bb739-ff50-4d29-b270-d6b0849064932026-09-09WarningsExact identifier
application number: M012
DRx Choice Children daytime Cough and Chest CongestionDEXTROMETHORPHAN HBR AND GUAIFENESINRARITAN PHARMACEUTICALS25fff2a6-ecb1-4117-bd11-e5ec3e3d09a92026-09-09WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc8a166067-b492-4742-b74c-28fac87c8d702026-09-09WarningsExact identifier
application number: M012
DRx Choice maximum strength Severe Cough plus sore throatACETAMINOPHEN, DEXTROMETHORPHAN HBRRARITAN PHARMACEUTICALSa096cb76-0d1c-4ca8-854a-5199da0bc8f72026-09-09WarningsExact identifier
application number: M012
Vicks DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTIONACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companyefb69cc1-a745-6efc-e053-2a95a90abdc92026-09-08WarningsExact identifier
application number: M012
Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTIONACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDEThe Procter & Gamble Manufacturing Companyefb5f0b9-9825-ab23-e053-2995a90a26ab2026-09-08WarningsExact identifier
application number: M012
Vicks DayQuil and Nyquil VapoCOOL Severe COLD and FLU plus CONGESTIONACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Companyf4328b44-cdfa-41aa-e053-2995a90a27282026-09-08WarningsExact identifier
application number: M012
Vicks childrens Cough CongestionPHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESINThe Procter & Gamble Manufacturing Companye2356457-9791-3710-e053-2995a90ad1402026-09-08WarningsExact identifier
application number: M012

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
71399-0023-671399002306473 mL in 1 BOTTLE (71399-0023-6) 473 ml2023-11-24NoNoCurrent