FDA.reportPublic FDA data

Vitastem-tetracycline hydrochloride

Product NDC
71262-003
11-digit product format
712620003
Labeler code
71262
Product ID
71262-003_52b9c813-a38e-3bd3-e063-6394a90ad142
Type
HUMAN OTC DRUG
Nonproprietary name
TETRACYCLINE HYDROCHLORIDE
Dosage form
SPRAY
Route
TOPICAL
Labeler
ViaDerma Distribution, Inc.
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-08-01
Substance
TETRACYCLINE HYDROCHLORIDE
Active strength
30 mg/mL
Pharmacologic classes
Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Vitastem-tetracycline hydrochloride
Listing expiration
2027-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2180656Internal RxNorm lookup
2180661Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7ffe82a4-864b-48c7-9307-d262f20ca01eAvailable 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
71262-003-00Vitastem-tetracycline hydrochloride55 mL in 1 BOTTLE, SPRAYSPRAY554
71262-003-00Vitastem-tetracycline hydrochloride1 in 1 BOXSPRAY14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71262-003VITASTEM-TETRACYCLINE HYDROCHLORIDE (TETRACYCLINE HYDROCHLORIDE) SPRAY [VIADERMA DISTRIBUTION, INC.]3Current NDC, Legacy NDC, 2 package rows20250125_7ffe82a4-864b-48c7-9307-d262f20ca01e.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 9 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antibiotic Maximum StrengthBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEWalgreens9a092f24-65b2-4b57-8103-265ea3e033112025-09-02WarningsExact identifier
application number: M004
AerosootheTRIPLE ANTIBIOTIC OINTMENTAero Healthcare US LLC2287a31c-750c-728d-e054-00144ff88e882025-08-29WarningsExact identifier
application number: M004
Triple Antibiotic Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEChain Drug Marketing Association Inc.3d4b3d73-171a-bc6a-e063-6394a90a69c12025-08-26WarningsExact identifier
application number: M004
Dual Action CreamNEOMYCINSULFATE,POLYMYXINBSULFATE,PRAMOXINEHCLTrifecta Pharmaceutical USA LLCb84015ae-9c76-b1d7-e053-2a95a90a2cc82025-08-23WarningsExact identifier
application number: M004
Natureplex Antibiotic Plus Pain, Itch, Scar ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDENatureplex LLCf0af8829-72fb-46b1-9328-6f4920710bb12025-08-15WarningsExact identifier
application number: M004
PROHEAL TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.6c61d88e-4ced-4468-8f99-91652f7a03e42025-08-13WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEJ&A Digital Inc.9f006f16-083d-4e95-aec2-6ef83405f3932025-08-07WarningsExact identifier
application number: M004
Vitacilina First Aid AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATETaisho Pharmaceutical California Inc.93fb9e05-f78c-4d37-b6f1-926cbcb2e7a72025-08-07WarningsExact identifier
application number: M004
SurviveX Triple AntibioticTRIPLE ANTIBIOTIC OINTMENTNantong Health & Beyond Hygienic Products Inc.3bd25bb6-6486-8a0a-e063-6394a90a085c2025-08-07WarningsExact identifier
application number: M004
Thera Plus Original Strength Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEFOURSTAR GROUP USA, INC.09e8bdb7-dc14-4f28-8306-c0e2bf73f0812025-07-31WarningsExact identifier
application number: M004
BacitracinBACITRACINBryant Ranch Prepack0c081802-429f-468f-9650-293cb7a1ad342025-07-29WarningsExact identifier
application number: M004
health and .beyond Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.0070ea5f-434d-53a7-e063-6294a90abf182025-07-27WarningsExact identifier
application number: M004
health and beyond TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.13cbe416-a146-447d-be36-8b3af9b3c8952025-07-27WarningsExact identifier
application number: M004
AOSI HEALTHCARE TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.70c53369-7cf6-4352-a19f-c85a55c5a4bd2025-07-27WarningsExact identifier
application number: M004
Pomada de SulfaNEOMYCIN SULFATEMenper Distributors, Inc.216f4d22-e5e8-46c8-a4ef-8d1532792b562025-07-22WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATESTRATEGIC SOURCING SERVICES LLC1bda9c30-8fc8-4814-b211-94550672b22f2025-07-21WarningsExact identifier
application number: M004
Triple Antibiotic plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLC6a61c900-2dfc-4c07-8ae5-32ffbd89d2b62025-07-21WarningsExact identifier
application number: M004
FifthPulse Bacitracin Zinc 1ozBACITRACIN ZINCFront Pharmaceutical PLC39f994d4-5f41-fb34-e063-6294a90a45ea2025-07-15WarningsExact identifier
application number: M004
FifthPulse Bacitracin Zinc 4ozBACITRACIN ZINCFront Pharmaceutical PLC39fa0e5f-b794-e1e3-e063-6394a90a4ce32025-07-15WarningsExact identifier
application number: M004
FifthPulse Hydrocortisone 1ozHYDROCORTISONEFront Pharmaceutical PLC39fae2a4-902e-3c88-e063-6394a90acbd52025-07-15WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2180656tetracycline HCl 3 % Topical SprayPSN7ffe82a4-864b-48c7-9307-d262f20ca01e4
2180661VITASTEM 3 % Topical SprayPSN7ffe82a4-864b-48c7-9307-d262f20ca01e4
2180661tetracycline hydrochloride 30 MG/ML Topical Spray [Vitastem]SBD7ffe82a4-864b-48c7-9307-d262f20ca01e4
2180656tetracycline hydrochloride 30 MG/ML Topical SpraySCD7ffe82a4-864b-48c7-9307-d262f20ca01e4
2180661Vitastem 3 % Topical SpraySY7ffe82a4-864b-48c7-9307-d262f20ca01e4
2180661Vitastem 30 MG/ML Topical SpraySY7ffe82a4-864b-48c7-9307-d262f20ca01e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71262-003-00712620003001 BOTTLE, SPRAY in 1 BOX (71262-003-00) / 55 mL in 1 BOTTLE, SPRAY2019-08-010000-00-00NoNoCurrent