Tetracyte Topical

Product NDC: 79790-001
Requested package NDC: 79790-001-00
11-digit product format: 797900001
Labeler code: 79790
Product ID: 79790-001_abaa24cb-fd39-f2b0-e053-2995a90af150
Type: HUMAN OTC DRUG
Nonproprietary name: TETRACYCLINE HYDROCHLORIDE
Dosage form: SPRAY
Route: TOPICAL
Labeler: WOUNDS PROS, LLC
Application: part333B
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2020-07-01
Marketing end: 0000-00-00
Substance: TETRACYCLINE HYDROCHLORIDE
Active strength: 30 mg/mL
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	79790-001	79790-001-00	I	Inactivated by FDA		2026-10-05

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, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
79790-001-00	2025-01-30	C162847	48780-1	2cef2736-70d8-d83d-e063-dadaa90ab31f	Tetracyte Topical Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
79790-001-00	Tetracyte Topical	1 in 1 BOX	SPRAY	1		3
79790-001-00	Tetracyte Topical	55 mL in 1 BOTTLE	SPRAY	55		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
79790-001	TETRACYTE TOPICAL (TETRACYCLINE HYDROCHLORIDE) SPRAY [WOUNDS PROS, LLC]	3	Legacy NDC, 2 package rows	20231202_f2bc68ac-5563-4ade-a75d-6517a7e97f72.zip

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
2180656	tetracycline HCl 3 % Topical Spray	PSN	f2bc68ac-5563-4ade-a75d-6517a7e97f72	3
2180656	tetracycline hydrochloride 30 MG/ML Topical Spray	SCD	f2bc68ac-5563-4ade-a75d-6517a7e97f72	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
79790-001-00	79790000100	1 BOTTLE in 1 BOX (79790-001-00) > 55 mL in 1 BOTTLE	1 bottle	2020-07-01	0000-00-00	No	No	Current