FDA.reportPublic FDA data

AXIV Allergy Relief

Product NDC
82706-021
11-digit product format
827060021
Labeler code
82706
Product ID
82706-021_1cd2a6f1-31ae-e507-e063-6394a90aba58
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
VIVUNT PHARMA LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-09
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
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

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
AXIV Allergy Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

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
1049630Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1cd2a6f1-31ad-e507-e063-6394a90aba58Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82706-021-02AXIV Allergy Relief50 in 1 CARTONTABLET501
82706-021-02AXIV Allergy Relief2 in 1 POUCHTABLET21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82706-021AXIV ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [VIVUNT PHARMA LLC]1Current NDC, 2 package rows20240720_1cd2a6f1-31ad-e507-e063-6394a90aba58.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 178 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold and AllergyPHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATEAllegiant Health7af63769-fa56-4f1f-a2ad-5b4c108c8e4f2019-12-12WarningsExact identifier
application number: M012
Mucus Relief Immediate ReleaseGUAIFENESINAllegiant Health221d64a2-b8c7-435a-aae4-fb58fd38108f2019-03-26WarningsExact identifier
application number: M012
Sleep Tabs For Nighttime useDIPHENHYDRAMINE HCL TABLETSAllegiant Health566e40b1-e9d7-44e4-b971-eef2b7cf0a7d2018-12-26WarningsExact identifier
application number: M012
AllergyCHLORPHENIRAMINE MALEATEAllegiant Health4305ad50-d2a5-4d3e-9d92-cbf26e856a162018-12-26WarningsExact identifier
application number: M012
Sleep AidDIPHENHYDRAMINE HCL 25 MGAllegiant Healthdbbc535f-515a-4d9b-b799-34e60f5230bb2018-12-21WarningsExact identifier
application number: M012
AllergyDIPHENHYDRAMINE HCLAllegiant Healthc2823bad-540f-4662-8dcc-58e9f0d94efb2018-11-07WarningsExact identifier
application number: M012
Nasal Decongestant PE Maximum Strength Non-DrowsyPHENYLEPHRINE 10 MGAllegiant Health7aef00df-816a-4ea2-a2ad-beed66dd2fe42018-11-07WarningsExact identifier
application number: M012
DEXTROMETHORPHAN HYDROBROMIDE, Guaifenesin, and PHENYLEPHRINE HYDROCHLORIDEDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEWestminster Pharmaceuticals, LLCa58bfb14-28f9-4425-a5a5-aaff4847c9792018-03-14WarningsExact identifier
application number: M012
Chlorpheniramine maleate 4mgCHLORPHENIRAMINE MALEATE 4MGAthlete's Needs, Inc.4d974959-25fc-4707-9b72-9afbf47b76f12017-11-14WarningsExact identifier
application number: M012
Cold MedicineACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLSelder, S.A. de C.V.d2762d9c-e7e7-42b2-a26a-14b2aa0307cb2017-01-25WarningsExact identifier
application number: M012
AllergyCHLORPHENIRAMINE MALEATEMarc Glassman, Inc.2051247f-ce64-4cf5-b449-9ca14c43ab862016-12-27WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN1cd2a6f1-31ad-e507-e063-6394a90aba581
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD1cd2a6f1-31ad-e507-e063-6394a90aba581

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82706-021-028270600210250 POUCH in 1 CARTON (82706-021-02) / 2 TABLET in 1 POUCH50 pouch2024-07-11NoNoCurrent