FDA.reportPublic FDA data

AXIV Allergy

Product NDC
82706-019
11-digit product format
827060019
Labeler code
82706
Product ID
82706-019_3f023cd0-2567-63dd-e063-6294a90a5dd4
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
VIVUNT PHARMA LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-08
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage82706-01982706-019-02DDiscontinued by firm2026-10-16

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
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
1049909Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1323a67c-b9c5-038c-e063-6394a90a5e6bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
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
82706-019-01AXIV Allergy2 in 1 CARTONCAPSULE, LIQUID FILLED24
82706-019-01AXIV Allergy12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED124
82706-019-02AXIV Allergy3 in 1 CARTONCAPSULE, LIQUID FILLED34
82706-019-02AXIV Allergy2 in 1 POUCHCAPSULE, LIQUID FILLED24
82706-019-03AXIV Allergy25 in 1 CARTONCAPSULE, LIQUID FILLED254
82706-019-03AXIV Allergy25 in 1 BLISTER PACKCAPSULE, LIQUID FILLED254

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82706-019AXIV ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [VIVUNT PHARMA LLC]3Current NDC, 6 package rows20250215_1323a67c-b9c5-038c-e063-6394a90a5e6b.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 70 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Throat Soothing Drops Creamy StrawberryTHROAT SOOTHING CREAMY STRAWBERRYCardinal Health 110, LLC. DBA Leader26cd146a-6461-604f-e063-6394a90ac36e2025-12-22WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS CREAMY STRAWBERRYMedical Group Care LLC043a5e11-30c3-44cd-e063-6394a90a318b2025-12-22WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS CHERRYMedical Group Care LLC29f3f6dd-751e-1dfe-e063-6394a90a0dbb2025-12-22WarningsExact identifier
application number: M012
MGC Cough DropsMENTHOLMedical Group Care LLC437f6b77-ecf8-2cd8-e063-6394a90ad45d2025-12-22WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS HONEYMedical Group Care LLCf4a92a69-e562-1cec-e053-2a95a90a01652025-12-22WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS VANILLA HONEYMedical Group Care LLC043999bc-3efe-5d29-e063-6294a90a95f42025-12-22WarningsExact identifier
application number: M012
MGC Health Throat Soothing Drops Creamy StrawberryPECTINMedical Group Care LLC3fa195b5-0712-aada-e063-6394a90a90692025-12-22WarningsExact identifier
application number: M012
QUALITY CHOICE Cough Drops Creamy StrawberryPECTIN, MENTHOLChain Drug Marketing Association, Inc.18d28b91-55a7-4d0d-8404-4f21afdef9892025-12-22WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS CHERRYDISCOUNT DRUG MART0668492e-c47e-b7cf-e063-6394a90a309b2025-12-22WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS MENTHOLDISCOUNT DRUG MART06574e56-13b8-a3af-e063-6394a90a48672025-12-22WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS HONEY LEMONDISCOUNT DRUG MART0668ddcc-0214-8e97-e063-6294a90a4f322025-12-22WarningsExact identifier
application number: M012
caring mill Cough drops CHERRYMENTHOLFSA STORE INC.9d666061-f7a8-4318-8db1-b65373689e1d2025-12-22WarningsExact identifier
application number: M012
Premier ValueCOUGH DROPS CHERRYPharmacy Value Alliance LLC018f4790-8785-94f4-e063-6394a90a19162025-12-22WarningsExact identifier
application number: M012
Premier ValueCOUGH DROPS HONEY LEMONPharmacy Value Alliance LLC0191fcf7-abc1-e583-e063-6294a90a78542025-12-22WarningsExact identifier
application number: M012
Premier ValueCOUGH DROPS MENTHOLPharmacy Value Alliance LLC019211bf-dd4b-5f4c-e063-6294a90aacfb2025-12-22WarningsExact identifier
application number: M012
Premier ValueCOUGH DROPS BLACK CHERRY SUGAR FREEPharmacy Value Alliance LLC018f20b1-06e0-eb13-e063-6394a90a5ec52025-12-22WarningsExact identifier
application number: M012
Quality Choice Cherry Cough DropsCHERRY COUGH DROPSChain Drug Marketing Association, Inc.6a407092-4b71-4156-b4ad-930782b5fb432025-12-22WarningsExact identifier
application number: M012
Quality Choice Honey Lemon Cough DropsHONEY LEMON COUGH DROPSChain Drug Marketing Association, Inc.1fd09b04-9c79-da20-e063-6394a90ae2632025-12-22WarningsExact identifier
application number: M012
Quality Choice Menthol Cough DropsMENTHOL COUGH DROPSChain Drug Marketing Association, Inc.3364470e-d9bb-42a6-9bd5-80c0bed8bc9e2025-12-22WarningsExact identifier
application number: M012
Quality Choice Honey Lemon Sugar Free Cough DropsHONEY LEMON SUGAR FREE COUGH DROPSChain Drug Marketing Association, Inc.1fd0a790-c67c-216f-e063-6294a90ae9712025-12-22WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN1323a67c-b9c5-038c-e063-6394a90a5e6b4
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD1323a67c-b9c5-038c-e063-6394a90a5e6b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82706-019-01827060019012 BLISTER PACK in 1 CARTON (82706-019-01) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2024-03-08NoNoCurrent
82706-019-02827060019023 in 1 CARTONHistorical
82706-019-038270600190325 BLISTER PACK in 1 CARTON (82706-019-03) / 25 CAPSULE, LIQUID FILLED in 1 BLISTER PACK25 blister pack2025-02-12NoNoCurrent