Vitastem

Product NDC: 71262-002
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	71262-002	71262-002-00	D	Discontinued by firm	2026-10-15
excluded package	package	71262-002	71262-002-01	D	Discontinued by firm	2026-10-15
excluded package	package	71262-002	71262-002-02	D	Discontinued by firm	2026-10-15

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 · 29 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71262-002-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71262-002-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71262-002-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71262-002-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71262-002-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71262-002-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71262-002-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71262-002-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71262-002-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71262-002-00	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71262-002-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71262-002-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71262-002-00	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71262-002-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71262-002-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71262-002-00	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71262-002-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71262-002-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71262-002-00	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71262-002-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71262-002-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71262-002-00	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71262-002-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71262-002-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71262-002-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71262-002-00	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71262-002-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71262-002-15	`0efc9e666f02…`	`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
Ingredient	Strength
TETRACYCLINE HYDROCHLORIDE	30 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
P6R62377KV	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
a6630858-7038-425f-8a75-bb25f36a0dbe	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15	Product name	1	20240313
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
151122cd-8b80-4972-8b02-3a4dda642fbc	Product name	2	20200701
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
bb6d6c68-649d-4e6d-a1f6-603d969c8f68	Product name	1	20160303
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
60c52429-fcef-eb54-2387-43bc9e4f296b	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71262-002-00	Vitastem	1 in 1 BOX	OINTMENT	1	10
71262-002-00	Vitastem	5 mL in 1 BOTTLE	OINTMENT	5	10
71262-002-01	Vitastem	1 in 1 BOX	OINTMENT	1	10
71262-002-01	Vitastem	60 mL in 1 BOTTLE	OINTMENT	60	10
71262-002-02	Vitastem	100 mL in 1 BOTTLE	OINTMENT	100	10
71262-002-02	Vitastem	1 in 1 BOX	OINTMENT	1	10
71262-002-15	Vitastem	15 mL in 1 BOTTLE	OINTMENT	15	10
71262-002-15	Vitastem	1 in 1 BOX	OINTMENT	1	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71262-002	VITASTEM (TETRACYCLINE HYDROCHLORIDE) OINTMENT [VIADERMA DISTRIBUTION, INC.]	10	Current NDC, Legacy NDC, 8 package rows	20250221_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 21 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leader Bacitracin Zinc	BACITRACIN ZINC	Cardinal Health 110 dba LEADER	a353dce2-8ae5-23aa-e053-2a95a90a89c2	2024-01-02	Warnings	Exact identifier application number: M004
Triple Antibiotic	POLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATE	NuCare Pharmaceuticals,Inc.	0dfe5f6a-6968-68e6-e063-6294a90ae25b	2024-01-02	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	Proficient Rx LP	e1166948-5d80-44c2-a20d-78be631647d9	2024-01-01	Warnings	Exact identifier application number: M004
TRIPLE ANTIBIOTIC	BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE	Proficient Rx LP	949c5b44-ee52-4913-8872-39181d319998	2024-01-01	Warnings	Exact identifier application number: M004
Triple Antibiotic Plus	POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, PRAMOXINE HCL	Cosette Pharmaceuticals, Inc.	69d911c2-cb89-2241-35f8-c83acfe18249	2023-12-21	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	Cosette Pharmaceuticals, Inc.	630e0841-baf2-e9fa-b309-ad1a5f95da3b	2023-12-20	Warnings	Exact identifier application number: M004
Triple Antibiotic	POLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATE	Cosette Pharmaceuticals, Inc.	39893365-c94f-bc83-67f6-0005d5f2aa24	2023-12-20	Warnings	Exact identifier application number: M004
Triple Antibiotic	POLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATE	Proficient Rx LP	524d65e7-9dc6-47b0-a924-46a765fa1869	2023-12-01	Warnings	Exact identifier application number: M004
Viabecline	TETRACYCLINE HYDROCHLORIDE	Accuria, LLC	9fd7041a-6c23-4332-90fe-759bb4aea2ae	2023-12-01	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	Proficient Rx LP	65f8fd49-1882-4eac-9c0e-d63968da33d4	2023-12-01	Warnings	Exact identifier application number: M004
Genuine First Aid Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	GFA Production(Xiamen) Co.,Ltd	0aaee474-cf35-8b39-e063-6294a90a815c	2023-11-21	Warnings	Exact identifier application number: M004
Sheffield Bacitracin Zinc	BACITRACIN ZINC	Sheffield Pharmaceuticals LLC	0f446f48-f55d-4de7-b447-285d7a329c84	2023-11-20	Warnings	Exact identifier application number: M004
Sheffield Triple Antibiotic Plus Pain Relief	BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDE	Sheffield Pharmaceuticals LLC	485a779c-017b-4064-a446-e5073c1bdb07	2023-11-20	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	BluePoint Laboratories	b4d8ef06-6269-68f7-e053-2995a90ac8ea	2023-11-17	Warnings	Exact identifier application number: M004
Bacitracin Zinc	FIRST AID ANTIBIOTIC	BluePoint Laboratories	d914abe1-5e14-5673-e053-2a95a90ac91b	2023-11-17	Warnings	Exact identifier application number: M004
EVERLIT CARE Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	EVERLIT GLOBAL INC.	e9157891-fc05-41a1-8a86-761a9ae56f8a	2023-11-14	Warnings	Exact identifier application number: M004
CR-371059 Tolnaftate 1%	CR-371059 TOLNAFTATE 1%	A-S Medication Solutions	bb4e4612-850c-4863-954d-7ad0500b9c05	2023-11-01	Warnings	Exact identifier application number: M004
Isopropyl Alcohol	ISOPROPYL ALCOHOL	A-S Medication Solutions	b44b07a0-91ff-476a-ae0a-080fa0191777	2023-10-31	Warnings	Exact identifier application number: M004
Family wellness	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	FRONT PHARMACEUTICAL PLC	bd3b8146-6271-488d-bf79-0bb659123b31	2023-10-27	Warnings	Exact identifier application number: M004
Family Wellness	BACITRACIN ZINC	FRONT PHARMACEUTICAL PLC	dfc148c1-d1bb-4230-b8cf-9457b99d4e8a	2023-10-27	Warnings	Exact identifier application number: M004

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
P6R62377KV	TETRACYCLINE HYDROCHLORIDE	64-75-5	TETRACYCLINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1542813	tetracycline HCl 3 % Topical Ointment	PSN	a6630858-7038-425f-8a75-bb25f36a0dbe	10
1542813	tetracycline hydrochloride 0.03 MG/MG Topical Ointment	SCD	a6630858-7038-425f-8a75-bb25f36a0dbe	10
1542813	tetracycline HCl 3 % Topical Ointment	SY	a6630858-7038-425f-8a75-bb25f36a0dbe	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71262-002-00	71262000200	1 BOTTLE in 1 BOX (71262-002-00) > 5 mL in 1 BOTTLE	1 bottle	2017-02-09	0000-00-00	No	No	Current
71262-002-01	71262000201	1 BOTTLE in 1 BOX (71262-002-01) > 60 mL in 1 BOTTLE	1 bottle	2016-11-08	0000-00-00	No	No	Current
71262-002-02	71262000202	1 BOTTLE in 1 BOX (71262-002-02) > 100 mL in 1 BOTTLE	1 bottle	2016-11-08	0000-00-00	No	No	Current
71262-002-15	71262000215	1 BOTTLE in 1 BOX (71262-002-15) / 15 mL in 1 BOTTLE	1 bottle	2017-07-01	0000-00-00	No	No	Current