sunmark

Product NDC: 49348-379
11-digit product format: 493480379
Labeler code: 49348
Product ID: 49348-379_93126403-13fc-45c3-9605-bbdde72a1a2f
Type: HUMAN OTC DRUG
Nonproprietary name: Clotrimazole
Dosage form: CREAM
Route: VAGINAL
Labeler: Strategic Sourcing Services LLC
Application: NDA021143
Marketing category: NDA
Marketing start: 2000-04-12
Marketing end: 0000-00-00
Substance: CLOTRIMAZOLE
Active strength: 2 g/100g
NDC exclude flag: No
Listing certified through: 2020-12-31
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	49348-379		D	Discontinued by firm		2026-11-13
excluded package	package	49348-379	49348-379-54	D	Discontinued by firm		2026-11-13

Source provenance: Browse the complete Orange Book source catalog · source snapshot 45.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021143-001	TRIVAGIZOLE 3	CLOTRIMAZOLE	2%	CREAM / VAGINAL			2000-04-12

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 45 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-11-14 07:37:17	2026-10	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`3bdfa0b2c4d7…`

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
b64d2752-34ef-378a-1f4f-8bff32b0d1ae	Product name	4	20250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9	Product name	2	20250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6	Product name	2	20151106
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508
f5395dd2-4395-d8c6-3477-8c2d4a2f951c	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49348-379-54	sunmarkClotrimazole 3	1 in 1 CARTON	CREAM	1		6
49348-379-54	sunmarkClotrimazole 3	21 g in 1 TUBE, WITH APPLICATOR	CREAM	21		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49348-379-54	GM - Gram	49348-379	2028325d-08d0-4d4b-9897-815e8d893164	1	2013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Clotrimazole	ACTIVE INGREDIENT	G07GZ97H65	SUNMARK CLOTRIMAZOLE 3 (CLOTRIMAZOLE) CREAM [MCKESSON]	1
Clotrimazole	ACTIVE MOIETY	G07GZ97H65	SUNMARK CLOTRIMAZOLE 3 (CLOTRIMAZOLE) CREAM [MCKESSON]	1
benzyl alcohol	INACTIVE INGREDIENT	LKG8494WBH	SUNMARK CLOTRIMAZOLE 3 (CLOTRIMAZOLE) CREAM [MCKESSON]	1
cetostearyl alcohol	INACTIVE INGREDIENT	2DMT128M1S	SUNMARK CLOTRIMAZOLE 3 (CLOTRIMAZOLE) CREAM [MCKESSON]	1
cetyl esters wax	INACTIVE INGREDIENT	D072FFP9GU	SUNMARK CLOTRIMAZOLE 3 (CLOTRIMAZOLE) CREAM [MCKESSON]	1
octyldodecanol	INACTIVE INGREDIENT	461N1O614Y	SUNMARK CLOTRIMAZOLE 3 (CLOTRIMAZOLE) CREAM [MCKESSON]	1
polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	SUNMARK CLOTRIMAZOLE 3 (CLOTRIMAZOLE) CREAM [MCKESSON]	1
sorbitan monostearate	INACTIVE INGREDIENT	NVZ4I0H58X	SUNMARK CLOTRIMAZOLE 3 (CLOTRIMAZOLE) CREAM [MCKESSON]	1
water	INACTIVE INGREDIENT	059QF0KO0R	SUNMARK CLOTRIMAZOLE 3 (CLOTRIMAZOLE) CREAM [MCKESSON]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49348-379	SUNMARK CLOTRIMAZOLE 3 (CLOTRIMAZOLE) CREAM [STRATEGIC SOURCING SERVICES LLC]	3	Legacy NDC, 2 package rows	20241211_0bc5d91a-c4ea-4fe9-80e0-6f76aa073e7b.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 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clotrimazole	CLOTRIMAZOLE	Foster and Thrive (Mckesson /STRATEGIC SOURCING SERVICES LLC)	474f5446-f9e3-4422-a9da-c7e23aaa0941	2025-07-30	Warnings	Exact identifier application applno (NDA): 021143 application number: NDA021143
Good Neighbor Pharmacy Clotrimazole 3	CLOTRIMAZOLE	AmerisourceBergen	2a7c3bd5-0ff4-46d2-b5d1-ef8637d0f530	2025-07-28	Warnings	Exact identifier application applno (NDA): 021143 application number: NDA021143
CVS Pharmacy Clotrimazole 3	CLOTRIMAZOLE	CVS Pharmacy	37000f9c-a1a4-4e5a-80c8-c9a1b2490a71	2025-07-17	Warnings	Exact identifier application applno (NDA): 021143 application number: NDA021143
Walgreens Clotrimazole 3	CLOTRIMAZOLE	Walgreen Company	7fafdebd-b117-4a6b-a499-a4d3ac086ab9	2025-07-08	Warnings	Exact identifier application applno (NDA): 021143 application number: NDA021143
Clotrimazole	CLOTRIMAZOLE	Sun Pharmaceutical Industries, Inc.	325a40b0-3e17-47c6-8988-d5396ca5d53f	2025-07-02	Warnings	Exact identifier application applno (NDA): 021143 application number: NDA021143

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G07GZ97H65	CLOTRIMAZOLE	23593-75-1	CLOTRIMAZOLE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199603	clotrimazole 2 % Vaginal Cream	PSN	0bc5d91a-c4ea-4fe9-80e0-6f76aa073e7b	6
199603	clotrimazole 20 MG/ML Vaginal Cream	SCD	0bc5d91a-c4ea-4fe9-80e0-6f76aa073e7b	6
199603	clotrimazole 2 % Vaginal Cream	SY	0bc5d91a-c4ea-4fe9-80e0-6f76aa073e7b	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
49348-379-54	49348037954	1 TUBE, WITH APPLICATOR in 1 CARTON (49348-379-54) > 21 g in 1 TUBE, WITH APPLICATOR	2013-02-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
sunmark ® Clotrimazole 3	Strategic Sourcing Services LLC \| Sun Pharma Canada Inc.	2025-07-21	HUMAN OTC DRUG LABEL	6