Silver Sulfadiazine

Product NDC
63187-023
11-digit product format
631870023
Labeler code
63187
Product ID
63187-023_cd81836d-38df-44dc-80a1-fb7ec7ba83e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Silver Sulfadiazine
Dosage form
CREAM
Route
TOPICAL
Labeler
Proficient Rx LP
Application
NDA018810
Marketing category
NDA
Marketing start
1985-12-23
Substance
SILVER SULFADIAZINE
Active strength
10 mg/g
Pharmacologic classes
Sulfonamide Antibacterial [EPC], Sulfonamides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63187-02363187-023-50DDiscontinued by firm2026-08-11

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 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018810-001THERMAZENESILVER SULFADIAZINE1%CREAM / TOPICALAB1985-12-23

Therapeutic equivalence codes#

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

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

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-2387673890dc5c…
2021-03-12 10:30 UTC2021-03N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-233f01610625f2…
2019-09-15 20:21 UTC2019-09N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-23b00525d2431f…
2019-07-19 19:46 UTC2019-07N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-233f0d92c62455…
2023-05-13 08:27 UTC2023-05N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-23053a50430f4f…
2023-01-26 05:58 UTC2023-01N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-23e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-23cb3db0bc1861…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N018810-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018810-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018810-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018810-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018810-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018810-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018810-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018810-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018810-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018810-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018810-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018810-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018810-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018810-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018810-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018810-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018810-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018810-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018810-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018810-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018810-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N018810-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018810-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018810-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018810-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N018810-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N018810-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018810-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018810-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018810-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018810-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018810-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018810-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018810-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N018810-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N018810-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018810-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018810-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018810-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018810-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Silver Sulfadiazine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILVER SULFADIAZINE10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
W46JY43EJRInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
106351Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
532d776e-54b3-4d4f-bb7a-94927bfba4d2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
52d15095-bb55-0cfb-f7b0-5be5a913b7dbProduct name120140508
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-023-25Silver Sulfadiazine25 g in 1 TUBECREAM257
63187-023-50Silver Sulfadiazine50 g in 1 TUBECREAM507
63187-023-51Silver Sulfadiazine50 g in 1 TUBECREAM507

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-023-25GM - Gram63187-023002912f7-0e1a-410f-b12b-df6ee37fc82b12016-04-04
63187-023-50GM - Gram63187-023d471a09b-4866-42e6-81dc-85ea2af561c512024-04-05
63187-023-51GM - Gram63187-0238e528e08-89e8-44cd-ad5b-fcf4d142a17412024-06-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SILVER SULFADIAZINEACTIVE INGREDIENTW46JY43EJRSILVER SULFADIAZINE CREAM [PROFICIENT RX LP]2
SULFADIAZINEACTIVE MOIETY0N7609K889SILVER SULFADIAZINE CREAM [PROFICIENT RX LP]2
Isopropyl MyristateINACTIVE INGREDIENT0RE8K4LNJSSILVER SULFADIAZINE CREAM [PROFICIENT RX LP]2
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TSILVER SULFADIAZINE CREAM [PROFICIENT RX LP]2
PetrolatumINACTIVE INGREDIENT4T6H12BN9USILVER SULFADIAZINE CREAM [PROFICIENT RX LP]2
Polyoxyl 40 StearateINACTIVE INGREDIENT13A4J4NH9ISILVER SULFADIAZINE CREAM [PROFICIENT RX LP]2
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3SILVER SULFADIAZINE CREAM [PROFICIENT RX LP]2
Sorbitan MonooleateINACTIVE INGREDIENT06XEA2VD56SILVER SULFADIAZINE CREAM [PROFICIENT RX LP]2
Stearyl AlcoholINACTIVE INGREDIENT2KR89I4H1YSILVER SULFADIAZINE CREAM [PROFICIENT RX LP]2
WaterINACTIVE INGREDIENT059QF0KO0RSILVER SULFADIAZINE CREAM [PROFICIENT RX LP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-023SILVER SULFADIAZINE CREAM [PROFICIENT RX LP]7Current NDC, Legacy NDC, 3 package rows20240310_532d776e-54b3-4d4f-bb7a-94927bfba4d2.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Silver sulfadiazineSILVER SULFADIAZINEAscend Laboratories, LLCb4d6694f-2b0a-4d64-9e05-2fef6d8e60d92026-07-13Warnings, Adverse reactionsExact identifier
application applno (NDA): 018810
application number: NDA018810
Thermazene Silver SulfadiazineSILVER SULFADIAZINEPreferred Pharmaceuticals, Inc.42c3ece4-0df0-4ed8-ac0f-a65fad19eed72026-02-16Warnings, Adverse reactionsExact identifier
application applno (NDA): 018810
application number: NDA018810
Silver SulfadiazineSILVER SULFADIAZINEAsclemed USA, Inc.4d9aa72e-b8dc-4ea3-be44-80f03ba819822026-01-23Warnings, Adverse reactionsExact identifier
application applno (NDA): 018810
application number: NDA018810
Silver SulfadiazineSILVER SULFADIAZINEA-S Medication Solutions72ca5cb5-14d2-45e4-8b53-ed5809b0aeca2025-12-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 018810
application number: NDA018810
Silver SulfadiazineSILVER SULFADIAZINEA-S Medication Solutions067895f9-a797-4cbd-a3d2-d611d512fe5b2025-06-17Warnings, Adverse reactionsExact identifier
application applno (NDA): 018810
application number: NDA018810
Silver SulfadiazineSILVER SULFADIAZINEBryant Ranch Prepack0084786a-09a3-4612-9afc-6733cc0cc56a2025-02-10Warnings, Adverse reactionsExact identifier
application applno (NDA): 018810
application number: NDA018810
Silver SulfadiazineSILVER SULFADIAZINEAdvanced Rx Pharmacy of Tennessee, LLCf1a0f489-0d9e-66c4-e053-2a95a90a063d2024-12-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 018810
application number: NDA018810
Silver SulfadiazineSILVER SULFADIAZINEA-S Medication Solutionsa4051ae4-f1ef-4082-920f-97d176b4cef22024-11-11Warnings, Adverse reactionsExact identifier
application applno (NDA): 018810
application number: NDA018810
Silver SulfadiazineSILVER SULFADIAZINEBryant Ranch Prepackede72069-2bb3-43e8-a45c-33ae3efeb9222024-10-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 018810
application number: NDA018810
Silver SulfadiazineSILVER SULFADIAZINEBryant Ranch Prepackd02fe8b9-2a20-40e7-8674-19768ff4d42d2024-10-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 018810
application number: NDA018810
Silver SulfadiazineSILVER SULFADIAZINEBryant Ranch Prepack3a04ce6d-4c38-4e21-8273-98a43d8c63592024-10-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 018810
application number: NDA018810
Silver SulfadiazineSILVER SULFADIAZINEBryant Ranch Prepackb3c0884b-2f6b-4608-9cab-bef2b370bc332024-10-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 018810
application number: NDA018810
Silver SulfadiazineSILVER SULFADIAZINEBryant Ranch Prepack3604ed05-8d91-475a-b950-2c114b3f890d2024-08-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 018810
application number: NDA018810
Silver SulfadiazineSILVER SULFADIAZINEProficient Rx LP532d776e-54b3-4d4f-bb7a-94927bfba4d22024-03-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 018810
application number: NDA018810
ndc (product): 63187-023
Silver SulfadiazineSILVER SULFADIAZINEA-S Medication Solutions475953ba-b555-474c-9bcd-8cd314cc0d1f2024-01-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 018810
application number: NDA018810

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106351silver sulfADIAZINE 1 % Topical CreamPSN532d776e-54b3-4d4f-bb7a-94927bfba4d27
106351silver sulfadiazine 10 MG/ML Topical CreamSCD532d776e-54b3-4d4f-bb7a-94927bfba4d27
106351silver sulfadiazine 1 % Topical CreamSY532d776e-54b3-4d4f-bb7a-94927bfba4d27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-023-256318700232525 g in 1 TUBE (63187-023-25) 25 g2018-11-010000-00-00NoNoCurrent
63187-023-506318700235050 g in 1 TUBE (63187-023-50) 50 g2018-11-010000-00-00NoNoCurrent
63187-023-516318700235150 g in 1 TUBE (63187-023-51) 50 g2024-02-14NoNoCurrent