FDA.reportPublic FDA data

Vitastem

Product NDC
71262-002
Requested package NDC
71262-002-01
11-digit product format
712620002
Labeler code
71262
Product ID
71262-002_2e71c67f-12a1-3588-e063-6394a90af7cf
Type
HUMAN OTC DRUG
Nonproprietary name
Tetracycline Hydrochloride
Dosage form
OINTMENT
Route
TOPICAL
Labeler
ViaDerma Distribution, Inc.
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-11-08
Substance
TETRACYCLINE HYDROCHLORIDE
Active strength
30 mg/mL
Pharmacologic classes
Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]
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 packagepackage71262-00271262-002-01DDiscontinued by firm2026-10-20

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 · 9 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…

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
Vitastem
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TETRACYCLINE HYDROCHLORIDE30 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
P6R62377KVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1542813Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a6630858-7038-425f-8a75-bb25f36a0dbeAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
151122cd-8b80-4972-8b02-3a4dda642fbcProduct name220200701
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303
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
71262-002-00Vitastem1 in 1 BOXOINTMENT110
71262-002-00Vitastem5 mL in 1 BOTTLEOINTMENT510
71262-002-01Vitastem1 in 1 BOXOINTMENT110
71262-002-01Vitastem60 mL in 1 BOTTLEOINTMENT6010
71262-002-02Vitastem100 mL in 1 BOTTLEOINTMENT10010
71262-002-02Vitastem1 in 1 BOXOINTMENT110
71262-002-15Vitastem15 mL in 1 BOTTLEOINTMENT1510
71262-002-15Vitastem1 in 1 BOXOINTMENT110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71262-002VITASTEM (TETRACYCLINE HYDROCHLORIDE) OINTMENT [VIADERMA DISTRIBUTION, INC.]10Current NDC, Legacy NDC, 8 package rows20250221_a6630858-7038-425f-8a75-bb25f36a0dbe.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 22 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Family Wellness Antiseptic and Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDEFRONT PHARMACEUTICAL PLCcb7fdcde-2bd8-4834-ba4e-4d6fd15125992023-10-26WarningsExact identifier
application number: M004
GENUINE FIRST AID AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.23abfe12-5b50-4b49-878e-4fcdb6c341fd2023-10-19WarningsExact identifier
application number: M004
EVERLIT CARE Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.f4921508-c32f-426f-a2f0-16c3acbd47132023-10-14WarningsExact identifier
application number: M004
CuadridermaBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDEProMex LLC4fa99b96-ab4b-4523-82bc-343dbaf39fb62022-01-25WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1542813tetracycline HCl 3 % Topical OintmentPSNa6630858-7038-425f-8a75-bb25f36a0dbe10
1542813tetracycline hydrochloride 0.03 MG/MG Topical OintmentSCDa6630858-7038-425f-8a75-bb25f36a0dbe10
1542813tetracycline HCl 3 % Topical OintmentSYa6630858-7038-425f-8a75-bb25f36a0dbe10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71262-002-01712620002011 BOTTLE in 1 BOX (71262-002-01) > 60 mL in 1 BOTTLE1 bottle2016-11-080000-00-00NoNoCurrent