AXIV - VroZzz

Product NDC
82706-014
11-digit product format
827060014
Labeler code
82706
Product ID
82706-014_3f053ed8-8c2a-be03-e063-6294a90ae5b7
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Vivunt Pharma LLC
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-07
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

Additional Listing Data#

Finished product
Yes
Brand name base
AXIV - VroZzz
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1049909

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
82706-014-01AXIV - VroZzz12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED125
82706-014-01AXIV - VroZzz6 in 1 CARTONCAPSULE, LIQUID FILLED65

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82706-014AXIV - VROZZZ (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [VIVUNT PHARMA LLC]4Current NDC, 2 package rows20240327_131a60cf-02ec-5a5b-e063-6294a90abd1f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN131a60cf-02ec-5a5b-e063-6294a90abd1f5
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD131a60cf-02ec-5a5b-e063-6294a90abd1f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82706-014-01827060014016 BLISTER PACK in 1 CARTON (82706-014-01) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK6 blister pack2024-03-07NoNoCurrent