SSD

Product NDC
50090-7447
11-digit product format
500907447
Labeler code
50090
Product ID
50090-7447_121d8f74-205c-48da-bf28-2fc9af22425d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Silver Sulfadiazine
Dosage form
CREAM
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
NDA018578
Marketing category
NDA
Marketing start
2011-05-04
Substance
SILVER SULFADIAZINE
Active strength
10 g/1000g
Pharmacologic classes
Sulfonamide Antibacterial [EPC], Sulfonamides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018578-001SSDSILVER SULFADIAZINE1%CREAM / TOPICALABRLD, RS1982-02-25
N018578-003SSD AFSILVER SULFADIAZINE1%CREAM / TOPICAL1990-07-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N018578-001AB

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N018578-001SSD1%CREAM / TOPICALABRLD, RS1982-02-25caaa826d4ba7…
2026-08-18 06:07:402026-07N018578-003SSD AF1%CREAM / TOPICAL1990-07-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018578-001SSD1%CREAM / TOPICALABRLD, RS1982-02-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018578-003SSD AF1%CREAM / TOPICAL1990-07-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018578-001SSD1%CREAM / TOPICALABRLD, RS1982-02-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018578-003SSD AF1%CREAM / TOPICAL1990-07-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018578-001SSD1%CREAM / TOPICALABRLD, RS1982-02-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018578-003SSD AF1%CREAM / TOPICAL1990-07-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018578-001SSD1%CREAM / TOPICALABRLD, RS1982-02-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018578-003SSD AF1%CREAM / TOPICAL1990-07-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018578-001SSD1%CREAM / TOPICALABRLD, RS1982-02-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018578-003SSD AF1%CREAM / TOPICAL1990-07-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018578-001SSD1%CREAM / TOPICALABRLD, RS1982-02-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018578-003SSD AF1%CREAM / TOPICAL1990-07-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018578-001SSD1%CREAM / TOPICALABRLD, RS1982-02-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018578-003SSD AF1%CREAM / TOPICAL1990-07-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018578-001SSD1%CREAM / TOPICALABRLD, RS1982-02-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018578-003SSD AF1%CREAM / TOPICAL1990-07-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018578-001SSD1%CREAM / TOPICALABRLD, RS1982-02-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018578-003SSD AF1%CREAM / TOPICAL1990-07-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018578-001SSD1%CREAM / TOPICALABRLD, RS1982-02-25d06236e962d9…
2024-10-29 15:01 UTC2024-10N018578-003SSD AF1%CREAM / TOPICAL1990-07-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018578-001SSD1%CREAM / TOPICALABRLD, RS1982-02-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018578-003SSD AF1%CREAM / TOPICAL1990-07-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018578-001SSD1%CREAM / TOPICALABRLD, RS1982-02-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018578-003SSD AF1%CREAM / TOPICAL1990-07-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018578-001SSD1%CREAM / TOPICALABRLD, RS1982-02-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018578-003SSD AF1%CREAM / TOPICAL1990-07-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018578-001SSD1%CREAM / TOPICALABRLD, RS1982-02-258072bd15b7f6…
2024-05-31 18:47 UTC2024-05N018578-003SSD AF1%CREAM / TOPICAL1990-07-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018578-001SSD1%CREAM / TOPICALAB1982-02-255c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018578-003SSD AF1%CREAM / TOPICAL1990-07-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018578-001SSD1%CREAM / TOPICALAB1982-02-255d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N018578-003SSD AF1%CREAM / TOPICAL1990-07-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018578-001SSD1%CREAM / TOPICALAB1982-02-254b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N018578-003SSD AF1%CREAM / TOPICAL1990-07-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018578-001SSD1%CREAM / TOPICALAB1982-02-2574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N018578-003SSD AF1%CREAM / TOPICAL1990-07-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018578-001SSD1%CREAM / TOPICALAB1982-02-25bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N018578-003SSD AF1%CREAM / TOPICAL1990-07-11bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N018578-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018578-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018578-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018578-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018578-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018578-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018578-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018578-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018578-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018578-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018578-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018578-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018578-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018578-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018578-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018578-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018578-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018578-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018578-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018578-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018578-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018578-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N018578-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018578-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018578-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018578-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N018578-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N018578-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018578-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018578-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018578-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018578-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018578-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018578-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018578-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N018578-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N018578-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018578-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018578-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018578-001AB1e64feba35796…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILVER SULFADIAZINE10 g/1000g

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
106351Internal RxNorm lookup
208185Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bf1367b4-3075-4373-8998-d9006f680df3Available 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
50090-7447-0SSD50 g in 1 JARCREAM501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7447-0GM - Gram50090-744752bec5cc-d0a5-47f9-9e3d-20a2b10a878b12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7447SSD (SILVER SULFADIAZINE) CREAM [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20241109_bf1367b4-3075-4373-8998-d9006f680df3.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SSD CreamSILVER SULFADIAZINESt. Mary's Medical Park Pharmacy24b01ac4-3ed5-db3d-e063-6394a90a06292026-06-10Warnings, Adverse reactionsExact identifier
application applno (NDA): 018578
application number: NDA018578
Silver SulfadiazineSILVER SULFADIAZINENuCare Pharmaceuticals,Inc.c6a40aee-ef43-e40b-e053-2995a90ae0482026-05-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 018578
application number: NDA018578
Silver SulfadiazineSILVER SULFADIAZINEDIRECT RX7ef0cf79-e960-44a6-acac-797913b71c972026-03-17Warnings, Adverse reactionsExact identifier
application applno (NDA): 018578
application number: NDA018578
SSD CreamSILVER SULFADIAZINEPreferred Pharmaceuticals Inc.cb7d2adf-d69d-4686-b9cf-c83d73acc4412025-09-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 018578
application number: NDA018578
SSD CreamSILVER SULFADIAZINENuCare Pharmaceuticals, Inc.37670ded-5d4a-4e98-e063-6394a90a15712025-06-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 018578
application number: NDA018578
SSDSILVER SULFADIAZINEA-S Medication Solutionsbf1367b4-3075-4373-8998-d9006f680df32024-11-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 018578
application number: NDA018578
ndc (product): 50090-7447
Silver SulfadiazineSILVER SULFADIAZINEAsclemed USA, Inc.bee162c3-2627-4f28-9715-11a351d497eb2022-03-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 018578
application number: NDA018578
SSD CreamSILVER SULFADIAZINEDr Reddys Laboratories Inc30d6dc33-e457-466b-9159-d8e7cd7918202019-04-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 018578
application number: NDA018578

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106351silver sulfADIAZINE 1 % Topical CreamPSNbf1367b4-3075-4373-8998-d9006f680df31
208185SSD 1 % Topical CreamPSNbf1367b4-3075-4373-8998-d9006f680df31
208185silver sulfadiazine 10 MG/ML Topical Cream [SSD]SBDbf1367b4-3075-4373-8998-d9006f680df31
106351silver sulfadiazine 10 MG/ML Topical CreamSCDbf1367b4-3075-4373-8998-d9006f680df31
106351silver sulfadiazine 1 % Topical CreamSYbf1367b4-3075-4373-8998-d9006f680df31
208185SSD 1 % Topical CreamSYbf1367b4-3075-4373-8998-d9006f680df31
208185SSD 10 MG/ML Topical CreamSYbf1367b4-3075-4373-8998-d9006f680df31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7447-05009074470050 g in 1 JAR (50090-7447-0) 50 g2024-11-07NoNoCurrent