Thermazene

Product NDC: 21695-182
11-digit product format: 216950182
Labeler code: 21695
Product ID: 21695-182_338f1552-e06e-4a6b-bd67-60737684a617
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Silver Sulfadiazine
Dosage form: CREAM
Route: TOPICAL
Labeler: Rebel Distributors Corp
Application: NDA018810
Marketing category: NDA
Marketing start: 1985-12-23
Marketing end: 0000-00-00
Substance: SILVER SULFADIAZINE
Active strength: 10 mg/g
Pharmacologic classes: Sulfonamide Antibacterial [EPC],Sulfonamides [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	21695-182		I	Inactivated by FDA	2026-08-11
excluded package	package	21695-182	21695-182-20	I	Inactivated by FDA	2026-08-11
excluded package	package	21695-182	21695-182-25	I	Inactivated by FDA	2026-08-11
excluded package	package	21695-182	21695-182-40	I	Inactivated by FDA	2026-08-11
excluded package	package	21695-182	21695-182-50	I	Inactivated by FDA	2026-08-11
excluded package	package	21695-182	21695-182-85	I	Inactivated by FDA	2026-08-11

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 3 · 132 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	21695-182-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-182-85	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-182-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-182-25	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-182-20	`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	21695-182-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-182-85	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-182-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-182-25	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-182-20	`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	21695-182-40	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-182-85	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-182-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-182-25	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-182-20	`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	21695-182-40	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-182-85	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-182-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-182-25	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-182-20	`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	21695-182-40	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-182-85	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-182-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-182-25	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-182-20	`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	21695-182-40	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-182-85	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-182-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-182-25	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-182-20	`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	21695-182-40	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-182-85	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-182-50	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-182-25	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-182-20	`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	21695-182-40	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-182-85	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-182-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-182-25	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-182-20	`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	21695-182-40	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-182-85	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-182-50	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-182-25	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-182-20	`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	21695-182-40	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-182-85	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-182-50	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-182-25	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-182-20	`ad56d346431e…`	`cc804d4bbf1e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N018810-001	THERMAZENE	SILVER SULFADIAZINE	1%	CREAM / TOPICAL	AB		1985-12-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N018810-001	AB

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018810-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018810-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018810-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018810-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018810-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018810-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018810-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018810-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018810-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018810-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018810-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018810-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018810-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018810-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018810-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018810-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018810-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018810-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018810-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018810-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018810-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018810-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018810-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018810-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018810-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018810-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018810-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018810-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018810-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018810-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018810-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018810-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018810-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018810-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018810-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018810-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018810-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018810-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018810-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018810-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6cca4355-1206-91f7-02de-17eef38a8622	Product name	1	20140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
21695-182-20	Ascend Laboratories, LLC Thermazene Silver Sulfadiazine Cream
21695-182-25	Ascend Laboratories, LLC Thermazene Silver Sulfadiazine Cream
21695-182-40	Ascend Laboratories, LLC Thermazene Silver Sulfadiazine Cream
21695-182-50	Ascend Laboratories, LLC Thermazene Silver Sulfadiazine Cream
21695-182-85	Ascend Laboratories, LLC Thermazene Silver Sulfadiazine Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
21695-182-20	ThermazeneSilver Sulfadiazine	20 g in 1 TUBE	CREAM	20	1
21695-182-25	ThermazeneSilver Sulfadiazine	25 g in 1 TUBE	CREAM	25	1
21695-182-40	ThermazeneSilver Sulfadiazine	400 g in 1 TUBE	CREAM	400	1
21695-182-50	ThermazeneSilver Sulfadiazine	50 g in 1 TUBE	CREAM	50	1
21695-182-85	ThermazeneSilver Sulfadiazine	85 g in 1 TUBE	CREAM	85	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-182-25	GM - Gram	21695-182	237fdcd2-a67a-4ee9-9a36-5b937feb383e	1	2012-07-24
21695-182-40	GM - Gram	21695-182	991eba78-4353-4944-b8aa-ca67d77240e8	1	2012-07-24
21695-182-50	GM - Gram	21695-182	182965de-89d4-4962-8b3e-fc5f1aac78f7	1	2012-07-24
21695-182-85	GM - Gram	21695-182	45788c74-7e28-42ac-86d5-a791271ae6c5	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Silver Sulfadiazine	ACTIVE INGREDIENT	W46JY43EJR	THERMAZENE SILVER SULFADIAZINE (SILVER SULFADIAZINE) CREAM [REBEL DISTRIBUTORS CORP]	1
Silver Sulfadiazine	ACTIVE MOIETY	W46JY43EJR	THERMAZENE SILVER SULFADIAZINE (SILVER SULFADIAZINE) CREAM [REBEL DISTRIBUTORS CORP]	1
Isopropyl Myristate	INACTIVE INGREDIENT	0RE8K4LNJS	THERMAZENE SILVER SULFADIAZINE (SILVER SULFADIAZINE) CREAM [REBEL DISTRIBUTORS CORP]	1
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	THERMAZENE SILVER SULFADIAZINE (SILVER SULFADIAZINE) CREAM [REBEL DISTRIBUTORS CORP]	1
Petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	THERMAZENE SILVER SULFADIAZINE (SILVER SULFADIAZINE) CREAM [REBEL DISTRIBUTORS CORP]	1
Polyoxyl 40 Stearate	INACTIVE INGREDIENT	13A4J4NH9I	THERMAZENE SILVER SULFADIAZINE (SILVER SULFADIAZINE) CREAM [REBEL DISTRIBUTORS CORP]	1
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	THERMAZENE SILVER SULFADIAZINE (SILVER SULFADIAZINE) CREAM [REBEL DISTRIBUTORS CORP]	1
Sorbitan Monooleate	INACTIVE INGREDIENT	06XEA2VD56	THERMAZENE SILVER SULFADIAZINE (SILVER SULFADIAZINE) CREAM [REBEL DISTRIBUTORS CORP]	1
Stearyl Alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	THERMAZENE SILVER SULFADIAZINE (SILVER SULFADIAZINE) CREAM [REBEL DISTRIBUTORS CORP]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	THERMAZENE SILVER SULFADIAZINE (SILVER SULFADIAZINE) CREAM [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-182	THERMAZENE SILVER SULFADIAZINE (SILVER SULFADIAZINE) CREAM [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 5 package rows	20101210_338f1552-e06e-4a6b-bd67-60737684a617.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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Silver sulfadiazine	SILVER SULFADIAZINE	Ascend Laboratories, LLC	b4d6694f-2b0a-4d64-9e05-2fef6d8e60d9	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018810 application number: NDA018810
Thermazene Silver Sulfadiazine	SILVER SULFADIAZINE	Preferred Pharmaceuticals, Inc.	42c3ece4-0df0-4ed8-ac0f-a65fad19eed7	2026-02-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018810 application number: NDA018810
Silver Sulfadiazine	SILVER SULFADIAZINE	Asclemed USA, Inc.	4d9aa72e-b8dc-4ea3-be44-80f03ba81982	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018810 application number: NDA018810
Silver Sulfadiazine	SILVER SULFADIAZINE	A-S Medication Solutions	72ca5cb5-14d2-45e4-8b53-ed5809b0aeca	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018810 application number: NDA018810
Silver Sulfadiazine	SILVER SULFADIAZINE	A-S Medication Solutions	067895f9-a797-4cbd-a3d2-d611d512fe5b	2025-06-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018810 application number: NDA018810
Silver Sulfadiazine	SILVER SULFADIAZINE	Bryant Ranch Prepack	0084786a-09a3-4612-9afc-6733cc0cc56a	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018810 application number: NDA018810
Silver Sulfadiazine	SILVER SULFADIAZINE	Advanced Rx Pharmacy of Tennessee, LLC	f1a0f489-0d9e-66c4-e053-2a95a90a063d	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018810 application number: NDA018810
Silver Sulfadiazine	SILVER SULFADIAZINE	A-S Medication Solutions	a4051ae4-f1ef-4082-920f-97d176b4cef2	2024-11-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018810 application number: NDA018810
Silver Sulfadiazine	SILVER SULFADIAZINE	Bryant Ranch Prepack	ede72069-2bb3-43e8-a45c-33ae3efeb922	2024-10-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018810 application number: NDA018810
Silver Sulfadiazine	SILVER SULFADIAZINE	Bryant Ranch Prepack	d02fe8b9-2a20-40e7-8674-19768ff4d42d	2024-10-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018810 application number: NDA018810
Silver Sulfadiazine	SILVER SULFADIAZINE	Bryant Ranch Prepack	3a04ce6d-4c38-4e21-8273-98a43d8c6359	2024-10-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018810 application number: NDA018810
Silver Sulfadiazine	SILVER SULFADIAZINE	Bryant Ranch Prepack	b3c0884b-2f6b-4608-9cab-bef2b370bc33	2024-10-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018810 application number: NDA018810
Silver Sulfadiazine	SILVER SULFADIAZINE	Bryant Ranch Prepack	3604ed05-8d91-475a-b950-2c114b3f890d	2024-08-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018810 application number: NDA018810
Silver Sulfadiazine	SILVER SULFADIAZINE	Proficient Rx LP	532d776e-54b3-4d4f-bb7a-94927bfba4d2	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018810 application number: NDA018810
Silver Sulfadiazine	SILVER SULFADIAZINE	A-S Medication Solutions	475953ba-b555-474c-9bcd-8cd314cc0d1f	2024-01-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018810 application number: NDA018810

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
W46JY43EJR	SILVER SULFADIAZINE	22199-08-2	SILVER SULFADIAZINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
21695-182-20	21695018220	20 g in 1 TUBE	20 g	Historical
21695-182-25	21695018225	25 g in 1 TUBE	25 g	Historical
21695-182-40	21695018240	400 g in 1 TUBE	400 g	Historical
21695-182-50	21695018250	50 g in 1 TUBE	50 g	Historical
21695-182-85	21695018285	85 g in 1 TUBE	85 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ascend Laboratories, LLC Thermazene Silver Sulfadiazine Cream	Rebel Distributors Corp	2010-12-01	HUMAN PRESCRIPTION DRUG LABEL	1