FDA.reportPublic FDA data

Vitastem ULTRA

Product NDC
71262-007
11-digit product format
712620007
Labeler code
71262
Product ID
71262-007_31e66bc1-9658-d154-e063-6394a90a708a
Type
HUMAN OTC DRUG
Nonproprietary name
BACITRACIN ZINC
Dosage form
OINTMENT
Route
TOPICAL
Labeler
ViaDerma Distribution, Inc
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-06-01
Substance
BACITRACIN ZINC
Active strength
500 U/mL
Pharmacologic classes
Decreased Cell Wall Synthesis & Repair [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Vitastem ULTRA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC500 U/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii89Y4M234ES
Rxcui1366116

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71262-007-15Vitastem ULTRA1 in 1 CARTONOINTMENT14
71262-007-15Vitastem ULTRA15 mL in 1 BOTTLEOINTMENT154
71262-007-55Vitastem ULTRA55 mL in 1 BOTTLEOINTMENT554
71262-007-55Vitastem ULTRA1 in 1 CARTONOINTMENT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71262-007VITASTEM ULTRA (BACITRACIN ZINC) OINTMENT [VIADERMA DISTRIBUTION, INC]3Current NDC, Legacy NDC, 4 package rows20250321_fd96cc09-8522-44a5-b034-0d30e532410d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1366116bacitracin zinc 500 UNT/GM Topical OintmentPSNfd96cc09-8522-44a5-b034-0d30e532410d4
1366116bacitracin zinc 0.5 UNT/MG Topical OintmentSCDfd96cc09-8522-44a5-b034-0d30e532410d4
1366116bacitracin zinc 500 UNT per GM Topical OintmentSYfd96cc09-8522-44a5-b034-0d30e532410d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71262-007-15712620007151 BOTTLE in 1 CARTON (71262-007-15) / 15 mL in 1 BOTTLE1 bottle2021-06-010000-00-00NoNoCurrent
71262-007-55712620007551 BOTTLE in 1 CARTON (71262-007-55) / 55 mL in 1 BOTTLE1 bottle2021-06-010000-00-00NoNoCurrent