Thermazene

Product NDC: 53097-101
11-digit product format: 530970101
Labeler code: 53097
Product ID: 53097-101_331af50e-8cf9-46f3-a8db-e76632739c92
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Silver Sulfadiazine
Dosage form: CREAM
Route: TOPICAL
Labeler: The Pharma Network LLC
Application: NDA018810
Marketing category: NDA
Marketing start: 2013-07-01
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: 2018-12-31
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 · 8 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53097-101		I	Inactivated by FDA	2026-08-11
excluded package	package	53097-101	53097-101-05	I	Inactivated by FDA	2026-08-11
excluded package	package	53097-101	53097-101-10	I	Inactivated by FDA	2026-08-11
excluded package	package	53097-101	53097-101-20	I	Inactivated by FDA	2026-08-11
excluded package	package	53097-101	53097-101-25	I	Inactivated by FDA	2026-08-11
excluded package	package	53097-101	53097-101-40	I	Inactivated by FDA	2026-08-11
excluded package	package	53097-101	53097-101-50	I	Inactivated by FDA	2026-08-11
excluded package	package	53097-101	53097-101-85	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 · 176 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	53097-101-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53097-101-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53097-101-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53097-101-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53097-101-85	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53097-101-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53097-101-25	`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	53097-101-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53097-101-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53097-101-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53097-101-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53097-101-85	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53097-101-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53097-101-25	`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	53097-101-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53097-101-40	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53097-101-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53097-101-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53097-101-85	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53097-101-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53097-101-25	`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	53097-101-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53097-101-40	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53097-101-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53097-101-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53097-101-85	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53097-101-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53097-101-25	`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	53097-101-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53097-101-40	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53097-101-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53097-101-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53097-101-85	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53097-101-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53097-101-25	`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	53097-101-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53097-101-40	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53097-101-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53097-101-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53097-101-85	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53097-101-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53097-101-25	`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	53097-101-50	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53097-101-40	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53097-101-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53097-101-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53097-101-85	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53097-101-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53097-101-25	`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	53097-101-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53097-101-40	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53097-101-05	`ed331223b511…`	`672a5bd82f5f…`

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
52d15095-bb55-0cfb-f7b0-5be5a913b7db	Product name	1	20140508
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
53097-101-05	b63d13c5-90e0-4de8-a075-795bfe8b91a1
53097-101-10	b63d13c5-90e0-4de8-a075-795bfe8b91a1
53097-101-20	b63d13c5-90e0-4de8-a075-795bfe8b91a1
53097-101-25	b63d13c5-90e0-4de8-a075-795bfe8b91a1
53097-101-40	b63d13c5-90e0-4de8-a075-795bfe8b91a1
53097-101-50	b63d13c5-90e0-4de8-a075-795bfe8b91a1
53097-101-85	b63d13c5-90e0-4de8-a075-795bfe8b91a1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53097-101-05	Thermazene	50 g in 1 JAR	CREAM	50	3
53097-101-10	Thermazene	1000 g in 1 JAR	CREAM	1000	3
53097-101-20	Thermazene	20 g in 1 TUBE	CREAM	20	3
53097-101-25	Thermazene	25 g in 1 TUBE	CREAM	25	3
53097-101-40	Thermazene	400 g in 1 JAR	CREAM	400	3
53097-101-50	Thermazene	50 g in 1 TUBE	CREAM	50	3
53097-101-85	Thermazene	85 g in 1 TUBE	CREAM	85	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53097-101-05	GM - Gram	53097-101	1be48834-2b08-4334-92c2-85808f6a7de6	1	2013-08-02
53097-101-10	GM - Gram	53097-101	c151f1af-d797-45b5-975d-dd7201b60357	1	2013-08-02
53097-101-20	GM - Gram	53097-101	b52fcb77-2237-408d-96e1-6d73eda4aee2	1	2013-08-02
53097-101-40	GM - Gram	53097-101	be629709-9a5c-49f5-9936-f003e19c59a7	1	2013-08-02
53097-101-50	GM - Gram	53097-101	d994a147-cc18-4230-bb1c-b0c1a7219329	1	2013-08-02
53097-101-85	GM - Gram	53097-101	895552de-1619-47a1-b5bd-a45dda579752	1	2013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SILVER SULFADIAZINE	ACTIVE INGREDIENT	W46JY43EJR	THERMAZENE (SILVER SULFADIAZINE) CREAM [THE PHARMA NETWORK LLC]	3
SULFADIAZINE	ACTIVE MOIETY	0N7609K889	THERMAZENE (SILVER SULFADIAZINE) CREAM [THE PHARMA NETWORK LLC]	3
Isopropyl Myristate	INACTIVE INGREDIENT	0RE8K4LNJS	THERMAZENE (SILVER SULFADIAZINE) CREAM [THE PHARMA NETWORK LLC]	3
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	THERMAZENE (SILVER SULFADIAZINE) CREAM [THE PHARMA NETWORK LLC]	3
Petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	THERMAZENE (SILVER SULFADIAZINE) CREAM [THE PHARMA NETWORK LLC]	3
Polyoxyl 40 Stearate	INACTIVE INGREDIENT	13A4J4NH9I	THERMAZENE (SILVER SULFADIAZINE) CREAM [THE PHARMA NETWORK LLC]	3
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	THERMAZENE (SILVER SULFADIAZINE) CREAM [THE PHARMA NETWORK LLC]	3
Sorbitan Monooleate	INACTIVE INGREDIENT	06XEA2VD56	THERMAZENE (SILVER SULFADIAZINE) CREAM [THE PHARMA NETWORK LLC]	3
Stearyl Alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	THERMAZENE (SILVER SULFADIAZINE) CREAM [THE PHARMA NETWORK LLC]	3
Water	INACTIVE INGREDIENT	059QF0KO0R	THERMAZENE (SILVER SULFADIAZINE) CREAM [THE PHARMA NETWORK LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53097-101	THERMAZENE (SILVER SULFADIAZINE) CREAM [THE PHARMA NETWORK LLC]	3	Legacy NDC, 7 package rows	20150116_b63d13c5-90e0-4de8-a075-795bfe8b91a1.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
106351	silver sulfADIAZINE 1 % Topical Cream	PSN	b63d13c5-90e0-4de8-a075-795bfe8b91a1	3
208187	Thermazene 1 % Topical Cream	PSN	b63d13c5-90e0-4de8-a075-795bfe8b91a1	3
208187	silver sulfadiazine 10 MG/ML Topical Cream [Thermazene]	SBD	b63d13c5-90e0-4de8-a075-795bfe8b91a1	3
106351	silver sulfadiazine 10 MG/ML Topical Cream	SCD	b63d13c5-90e0-4de8-a075-795bfe8b91a1	3
106351	silver sulfadiazine 1 % Topical Cream	SY	b63d13c5-90e0-4de8-a075-795bfe8b91a1	3
208187	Thermazene 1 % Topical Cream	SY	b63d13c5-90e0-4de8-a075-795bfe8b91a1	3
208187	Thermazene 10 MG/ML Topical Cream	SY	b63d13c5-90e0-4de8-a075-795bfe8b91a1	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
53097-101-05	53097010105	50 g in 1 JAR	50 g	Historical
53097-101-10	53097010110	1000 g in 1 JAR	1000 g	Historical
53097-101-20	53097010120	20 g in 1 TUBE	20 g	Historical
53097-101-25	53097010125	25 g in 1 TUBE	25 g	Historical
53097-101-40	53097010140	400 g in 1 JAR	400 g	Historical
53097-101-50	53097010150	50 g in 1 TUBE	50 g	Historical
53097-101-85	53097010185	85 g in 1 TUBE	85 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Thermazene - The Pharma Network LLC \| Crown Laboratories, Inc.	The Pharma Network LLC \| Crown Laboratories, Inc.	2015-01-15	HUMAN PRESCRIPTION DRUG LABEL	3