TetraStem

Product NDC: 43074-301
11-digit product format: 430740301
Labeler code: 43074
Product ID: 43074-301_e739bfd8-0b05-48b3-859e-e6400d67b721
Type: HUMAN OTC DRUG
Nonproprietary name: TETRACYCLINE HYDROCHLORIDE
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Phillips Company
Application: part333B
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2014-02-25
Marketing end: 0000-00-00
Substance: TETRACYCLINE HYDROCHLORIDE
Active strength: 30 mg/g
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	43074-301		I	Inactivated by FDA		2026-08-17
excluded package	package	43074-301	43074-301-11	I	Inactivated by FDA		2026-08-17

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 · 42 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 product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43074-301-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43074-301-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43074-301-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43074-301-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43074-301-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43074-301-11	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43074-301-11	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43074-301-11	`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	43074-301-11	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43074-301-11	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43074-301-11	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43074-301-11	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	43074-301-11	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	43074-301-11	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	43074-301-11	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	43074-301-11	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	43074-301-11	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	43074-301-11	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	43074-301-11	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	43074-301-11	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	43074-301-11	`9bebd1f3094a…`	`5416666fcb17…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43074-301-11	2020-01-31	C162847	48780-1	9d75b9d0-4a65-f424-e053-dadaa90a57ce	TetraStem - Topical Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43074-301-11	TetraStem	3 g in 1 BOTTLE	OINTMENT	3		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TETRACYCLINE HYDROCHLORIDE	ACTIVE INGREDIENT	P6R62377KV	TETRASTEM (TETRACYCLINE HYDROCHLORIDE) OINTMENT [PHILLIPS COMPANY]	1
TETRACYCLINE	ACTIVE MOIETY	F8VB5M810T	TETRASTEM (TETRACYCLINE HYDROCHLORIDE) OINTMENT [PHILLIPS COMPANY]	1
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	TETRASTEM (TETRACYCLINE HYDROCHLORIDE) OINTMENT [PHILLIPS COMPANY]	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	TETRASTEM (TETRACYCLINE HYDROCHLORIDE) OINTMENT [PHILLIPS COMPANY]	1
CHLORHEXIDINE GLUCONATE	INACTIVE INGREDIENT	MOR84MUD8E	TETRASTEM (TETRACYCLINE HYDROCHLORIDE) OINTMENT [PHILLIPS COMPANY]	1
CHOLECALCIFEROL	INACTIVE INGREDIENT	1C6V77QF41	TETRASTEM (TETRACYCLINE HYDROCHLORIDE) OINTMENT [PHILLIPS COMPANY]	1
DIMETHYL SULFOXIDE	INACTIVE INGREDIENT	YOW8V9698H	TETRASTEM (TETRACYCLINE HYDROCHLORIDE) OINTMENT [PHILLIPS COMPANY]	1
DIPROPYLENE GLYCOL	INACTIVE INGREDIENT	E107L85C40	TETRASTEM (TETRACYCLINE HYDROCHLORIDE) OINTMENT [PHILLIPS COMPANY]	1
GLUCONOLACTONE	INACTIVE INGREDIENT	WQ29KQ9POT	TETRASTEM (TETRACYCLINE HYDROCHLORIDE) OINTMENT [PHILLIPS COMPANY]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	TETRASTEM (TETRACYCLINE HYDROCHLORIDE) OINTMENT [PHILLIPS COMPANY]	1
HISTIDINE	INACTIVE INGREDIENT	4QD397987E	TETRASTEM (TETRACYCLINE HYDROCHLORIDE) OINTMENT [PHILLIPS COMPANY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TETRASTEM (TETRACYCLINE HYDROCHLORIDE) OINTMENT [PHILLIPS COMPANY]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	TETRASTEM (TETRACYCLINE HYDROCHLORIDE) OINTMENT [PHILLIPS COMPANY]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	TETRASTEM (TETRACYCLINE HYDROCHLORIDE) OINTMENT [PHILLIPS COMPANY]	1
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	TETRASTEM (TETRACYCLINE HYDROCHLORIDE) OINTMENT [PHILLIPS COMPANY]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	TETRASTEM (TETRACYCLINE HYDROCHLORIDE) OINTMENT [PHILLIPS COMPANY]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	TETRASTEM (TETRACYCLINE HYDROCHLORIDE) OINTMENT [PHILLIPS COMPANY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43074-301	TETRASTEM (TETRACYCLINE HYDROCHLORIDE) OINTMENT [PHILLIPS COMPANY]	1	Legacy NDC, 1 package rows	20140225_1c6c18db-5e42-4942-a611-00d49651a91f.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
1542813	tetracycline HCl 3 % Topical Ointment	PSN	1c6c18db-5e42-4942-a611-00d49651a91f	1
1542813	tetracycline hydrochloride 0.03 MG/MG Topical Ointment	SCD	1c6c18db-5e42-4942-a611-00d49651a91f	1
1542813	tetracycline HCl 3 % Topical Ointment	SY	1c6c18db-5e42-4942-a611-00d49651a91f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
43074-301-11	43074030111	3 g in 1 BOTTLE	3 g	Historical