SILVADENE

Product NDC
61570-131
11-digit product format
615700131
Labeler code
61570
Product ID
61570-131_2d9a5dc8-0dfd-42b8-a641-b4b82a113fab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
silver sulfadiazine
Dosage form
CREAM
Route
TOPICAL
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
NDA017381
Marketing category
NDA
Marketing start
1973-11-26
Substance
SILVER SULFADIAZINE
Active strength
10 mg/g
Pharmacologic classes
Sulfonamide Antibacterial [EPC], Sulfonamides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
N017381-001SILVADENESILVER SULFADIAZINE1%CREAM / TOPICALABRLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N017381-001AB

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 UTC2026-02N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 1982cb3db0bc1861…

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 UTC2026-02N017381-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017381-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N017381-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017381-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017381-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017381-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017381-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017381-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017381-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017381-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017381-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017381-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017381-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017381-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017381-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N017381-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N017381-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N017381-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N017381-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N017381-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017381-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N017381-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N017381-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N017381-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N017381-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N017381-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N017381-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017381-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N017381-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N017381-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N017381-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N017381-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N017381-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N017381-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N017381-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N017381-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N017381-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N017381-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017381-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017381-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
SILVADENE
Listing expiration
2027-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
106351Internal RxNorm lookup
208186Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c437213a-1cd4-445e-a39f-bbcacb9f746fAvailable 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
61570-131-20SILVADENE20 g in 1 TUBECREAM2019
61570-131-20SILVADENE1 in 1 CARTONCREAM119
61570-131-25SILVADENE25 g in 1 TUBECREAM2519
61570-131-25SILVADENE1 in 1 CARTONCREAM119
61570-131-40SILVADENE400 g in 1 JARCREAM40019
61570-131-50SILVADENE50 g in 1 JARCREAM5019
61570-131-55SILVADENE50 g in 1 TUBECREAM5019
61570-131-55SILVADENE1 in 1 CARTONCREAM119
61570-131-85SILVADENE85 g in 1 TUBECREAM8519
61570-131-85SILVADENE1 in 1 CARTONCREAM119
61570-131-98SILVADENE1000 g in 1 JARCREAM100019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61570-131-20GM - Gram61570-131576c1b70-a780-45cd-a7ef-0840e969f9b112012-07-24
61570-131-25GM - Gram61570-131b8b498b2-3a5b-4b40-a462-f1e324c618b912015-06-09
61570-131-40GM - Gram61570-131fd1ebb66-40d9-4c78-b50b-5e3ca7eb5bbc12012-07-24
61570-131-50GM - Gram61570-131c8c5af05-c4c6-452e-bd7c-d58876746ca012012-07-24
61570-131-55GM - Gram61570-131b0eff2f2-0a48-4c26-a939-903c46efa89912015-06-09
61570-131-85GM - Gram61570-131d62270e4-6159-4aaf-807a-ade34036b0da12012-07-24
61570-131-98GM - Gram61570-1310bc2a501-ea49-4b58-8a45-3d093c8c89c712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SILVER SULFADIAZINEACTIVE INGREDIENTW46JY43EJRSILVADENE (SILVER SULFADIAZINE) CREAM [PFIZER LABORATORIES DIV PFIZER INC]9
SULFADIAZINEACTIVE MOIETY0N7609K889SILVADENE (SILVER SULFADIAZINE) CREAM [PFIZER LABORATORIES DIV PFIZER INC]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61570-131SILVADENE (SILVER SULFADIAZINE) CREAM [PFIZER LABORATORIES DIV PFIZER INC]17Current NDC, Legacy NDC, 11 package rows20210717_c437213a-1cd4-445e-a39f-bbcacb9f746f.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SILVADENESILVER SULFADIAZINEPfizer Laboratories Div Pfizer Incc437213a-1cd4-445e-a39f-bbcacb9f746f2026-01-26Warnings, Adverse reactionsExact identifier
application applno (NDA): 017381
application number: NDA017381
ndc (product): 61570-131
SILVER SULFADIAZINESILVER SULFADIAZINEMylan Pharmaceuticals Inc.7a6a9590-9983-46ff-ae5c-fe95f4e16cb82025-12-26Warnings, Adverse reactionsExact identifier
application applno (NDA): 017381
application number: NDA017381
SILVADENESILVER SULFADIAZINEA-S Medication Solutions54b77a36-205b-4044-9ecb-c5130f0934b52023-12-09Warnings, Adverse reactionsExact identifier
application applno (NDA): 017381
application number: NDA017381

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
208186Silvadene 1 % Topical CreamPSNc437213a-1cd4-445e-a39f-bbcacb9f746f19
106351silver sulfADIAZINE 1 % Topical CreamPSNc437213a-1cd4-445e-a39f-bbcacb9f746f19
208186silver sulfadiazine 10 MG/ML Topical Cream [Silvadene]SBDc437213a-1cd4-445e-a39f-bbcacb9f746f19
106351silver sulfadiazine 10 MG/ML Topical CreamSCDc437213a-1cd4-445e-a39f-bbcacb9f746f19
208186Silvadene 1 % Topical CreamSYc437213a-1cd4-445e-a39f-bbcacb9f746f19
208186Silvadene 10 MG/ML Topical CreamSYc437213a-1cd4-445e-a39f-bbcacb9f746f19
106351silver sulfadiazine 1 % Topical CreamSYc437213a-1cd4-445e-a39f-bbcacb9f746f19
208186Silvadene 1 % Topical CreamPSN54b77a36-205b-4044-9ecb-c5130f0934b518
106351silver sulfADIAZINE 1 % Topical CreamPSN54b77a36-205b-4044-9ecb-c5130f0934b518
208186silver sulfadiazine 10 MG/ML Topical Cream [Silvadene]SBD54b77a36-205b-4044-9ecb-c5130f0934b518
106351silver sulfadiazine 10 MG/ML Topical CreamSCD54b77a36-205b-4044-9ecb-c5130f0934b518
208186Silvadene 1 % Topical CreamSY54b77a36-205b-4044-9ecb-c5130f0934b518
208186Silvadene 10 MG/ML Topical CreamSY54b77a36-205b-4044-9ecb-c5130f0934b518
106351silver sulfadiazine 1 % Topical CreamSY54b77a36-205b-4044-9ecb-c5130f0934b518
208186Silvadene 1 % Topical CreamPSN9b6715e6-4117-4a22-b219-ce0ba5bb2fa71
106351silver sulfADIAZINE 1 % Topical CreamPSN9b6715e6-4117-4a22-b219-ce0ba5bb2fa71
208186silver sulfadiazine 10 MG/ML Topical Cream [Silvadene]SBD9b6715e6-4117-4a22-b219-ce0ba5bb2fa71
106351silver sulfadiazine 10 MG/ML Topical CreamSCD9b6715e6-4117-4a22-b219-ce0ba5bb2fa71
208186Silvadene 1 % Topical CreamSY9b6715e6-4117-4a22-b219-ce0ba5bb2fa71
208186Silvadene 10 MG/ML Topical CreamSY9b6715e6-4117-4a22-b219-ce0ba5bb2fa71
106351silver sulfadiazine 1 % Topical CreamSY9b6715e6-4117-4a22-b219-ce0ba5bb2fa71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61570-131-20615700131201 TUBE in 1 CARTON (61570-131-20) / 20 g in 1 TUBE1 tube1973-11-260000-00-00NoNoCurrent
61570-131-25615700131251 TUBE in 1 CARTON (61570-131-25) / 25 g in 1 TUBE1 tube2015-05-260000-00-00NoNoCurrent
61570-131-4061570013140400 g in 1 JAR (61570-131-40) 400 g1973-11-260000-00-00NoNoCurrent
61570-131-506157001315050 g in 1 JAR (61570-131-50) 50 g1973-11-260000-00-00NoNoCurrent
61570-131-55615700131551 TUBE in 1 CARTON (61570-131-55) / 50 g in 1 TUBE1 tube2015-05-260000-00-00NoNoCurrent
61570-131-85615700131851 TUBE in 1 CARTON (61570-131-85) / 85 g in 1 TUBE1 tube1973-11-260000-00-00NoNoCurrent
61570-131-98615700131981000 g in 1 JAR (61570-131-98) 1000 g1973-11-260000-00-00NoNoCurrent