FDA.reportPublic FDA data

TRIDERM

Product NDC
0316-0170
11-digit product format
003160170
Labeler code
0316
Product ID
0316-0170_4834365b-0f43-13a2-e063-6294a90a9f33
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamcinolone Acetonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Crown Laboratories
Application
ANDA088042
Marketing category
ANDA
Marketing start
1984-03-19
Substance
TRIAMCINOLONE ACETONIDE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A088042-001TRIDERMTRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1984-03-19
A088042-002TRIDERMTRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALAT2015-03-25
A088042-003TRIDERMTRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALAT2015-03-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A088042-001AT
A088042-002AT
A088042-003AT

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A088042-001TRIDERM0.1%CREAM / TOPICALAT1984-03-19a50c72e98297…
2026-08-01 22:54:322026-06A088042-002TRIDERM0.025%CREAM / TOPICALAT2015-03-25a50c72e98297…
2026-08-01 22:54:322026-06A088042-003TRIDERM0.5%CREAM / TOPICALAT2015-03-25a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A088042-001AT1a50c72e98297…
2026-08-01 22:54:322026-06A088042-002AT1a50c72e98297…
2026-08-01 22:54:322026-06A088042-003AT1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 32 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEAscend Laboratories, LLCccca8660-124e-4220-8d87-4b9aeecbda7d2026-07-13Adverse reactionsExact identifier
application applno (ANDA): 088042
application number: ANDA088042
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEBryant Ranch Prepackb2ba93bc-3775-466b-8daf-4ffa3edc9c002026-05-28Adverse reactionsExact identifier
application applno (ANDA): 088042
application number: ANDA088042
Triamcinolone acetonideTRIAMCINOLONE ACETONIDEBryant Ranch Prepack3fc24a96-91b0-46bd-bf16-b3d5739e9c072026-04-14Adverse reactionsExact identifier
application applno (ANDA): 088042
application number: ANDA088042
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEDirect_Rx4d29394d-4725-f912-e063-6294a90a062c2026-04-08Adverse reactionsExact identifier
application applno (ANDA): 088042
application number: ANDA088042
Triamcinolone acetonideTRIAMCINOLONE ACETONIDEBryant Ranch Prepack6658728a-99d7-48c3-83d6-4e40c59c9b472026-04-07Adverse reactionsExact identifier
application applno (ANDA): 088042
application number: ANDA088042
Triamcinolone acetonideTRIAMCINOLONE ACETONIDEA-S Medication Solutions10cf5e2f-0e9f-4fc0-af4a-3be46a4af4752026-04-02Adverse reactionsExact identifier
application applno (ANDA): 088042
application number: ANDA088042
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEDirect_Rx93de78fb-1f19-cfc6-e053-2995a90a9bc72026-03-05Adverse reactionsExact identifier
application applno (ANDA): 088042
application number: ANDA088042
Triamcinolone acetonideTRIAMCINOLONE ACETONIDENuCare Pharmaceuticals,Inc.bd45c7d2-a1a3-e0f5-e053-2a95a90ae4b32026-02-19Adverse reactionsExact identifier
application applno (ANDA): 088042
application number: ANDA088042
Triamcinolone acetonideTRIAMCINOLONE ACETONIDEA-S Medication Solutions96f18791-480d-49f2-aac6-387321ae552c2026-02-14Adverse reactionsExact identifier
application applno (ANDA): 088042
application number: ANDA088042
Triamcinolone acetonideTRIAMCINOLONE ACETONIDEA-S Medication Solutions51fedf94-d94e-42b7-8e9f-e0e9b6bbd0552026-02-11Adverse reactionsExact identifier
application applno (ANDA): 088042
application number: ANDA088042
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEREMEDYREPACK INC.d53c1728-6846-4e7d-a772-8b54ba9529b02026-01-26Adverse reactionsExact identifier
application applno (ANDA): 088042
application number: ANDA088042
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEREMEDYREPACK INC.87045b25-4d54-44fa-baed-1aefdad985742026-01-14Adverse reactionsExact identifier
application applno (ANDA): 088042
application number: ANDA088042
TRIDERMTRIAMCINOLONE ACETONIDECrown Laboratories2c7fee2c-6f57-4de4-8803-98c0b31b07c32026-01-12Adverse reactionsExact identifier
application applno (ANDA): 088042
application number: ANDA088042
ndc (product): 0316-0170
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEBryant Ranch Prepack04ef72a9-6aa1-4d64-b598-f281215229a42025-11-07Adverse reactionsExact identifier
application applno (ANDA): 088042
application number: ANDA088042
Triamcinolone acetonideTRIAMCINOLONE ACETONIDEPreferred Pharmaceuticals Inc.777c3cb9-da2b-431c-934f-f3c70f93d6cb2025-10-01Adverse reactionsExact identifier
application applno (ANDA): 088042
application number: ANDA088042
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEBryant Ranch Prepackf549f9ea-abc0-4fc2-b6ec-c21182eb26e62025-09-22Adverse reactionsExact identifier
application applno (ANDA): 088042
application number: ANDA088042
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEBryant Ranch Prepackd870041e-7c92-4f88-a305-ecb8f50a57732025-07-28Adverse reactionsExact identifier
application applno (ANDA): 088042
application number: ANDA088042
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEBryant Ranch Prepack20fa27ca-807a-4513-8af5-a835541d60d52025-07-28Adverse reactionsExact identifier
application applno (ANDA): 088042
application number: ANDA088042
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEBryant Ranch Prepackd086c38e-99c7-4d25-a722-a61c77d3989b2025-07-28Adverse reactionsExact identifier
application applno (ANDA): 088042
application number: ANDA088042
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEPreferred Pharmaceuticals Inc.d0428b54-c4f5-46f1-a65e-7e20c56dbe782025-07-10Adverse reactionsExact identifier
application applno (ANDA): 088042
application number: ANDA088042

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIAMCINOLONE ACETONIDE1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F446C597KAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1014314Internal RxNorm lookup
1085644Internal RxNorm lookup
1085686Internal RxNorm lookup
1085773Internal RxNorm lookup
1648997Internal RxNorm lookup
1648999Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2c7fee2c-6f57-4de4-8803-98c0b31b07c3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d4d7da1a-7fd4-628e-cdae-89e749b1c534Product name720260127
75f7e47b-8736-a182-fc44-22aca8d79689Product name220251211
62986c8d-91f1-b1ba-b5a3-8b54b75bb8c2Product name620250516
e42f429b-c4e5-0402-e1c5-730154df4060Product name420240205
38d4de13-64b3-4057-b91c-4b5126962341Product name120220516
089e0644-1ea8-8654-4113-39f960dd57d5Product name320210115
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
5331c9c8-f64b-11e6-ccf1-071c477fcb0bProduct name720190612
9f64e0dc-109c-9660-8e0e-91ec987b3817Product name620171204
dfa879a3-32de-49f0-a7ba-9b9c3e13002fProduct name120171204
8de20f81-8411-4cf1-a8b2-03404ee56d01Product name320171109
a5f1a68c-0352-4f34-46a3-9b4eed239ed8Product name220160819
355b2224-0895-7135-83f5-d099a6a82a0aProduct name120140508
55be6b50-8cc0-f0f1-74a1-3416a91193aaProduct name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
7a0092d1-1e8c-0d78-4f8d-d95fa15cc3cfProduct name120140508
89b93c13-4be8-69f3-b33b-63e64feffb9bProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0316-0170-012023-02-13C16284748780-1f386c649-b13d-0266-e053-dadaa90a7c1aTRIDERM (Triamcinolone Acetonide Cream USP), 0.025%, 0.1%, 0.5%
0316-0170-012023-02-13C16284748780-1f386c649-b13d-0266-e053-dadaa90a7c1aTRIDERM (Triamcinolone Acetonide Cream USP), 0.025%, 0.1%, 0.5%
0316-0170-012023-02-13C16284748780-1f386c649-b13d-0266-e053-dadaa90a7c1aTRIDERM (Triamcinolone Acetonide Cream USP), 0.025%, 0.1%, 0.5%
0316-0170-022023-02-13C16284748780-1f386c649-b13d-0266-e053-dadaa90a7c1aTRIDERM (Triamcinolone Acetonide Cream USP), 0.025%, 0.1%, 0.5%
0316-0170-022023-02-13C16284748780-1f386c649-b13d-0266-e053-dadaa90a7c1aTRIDERM (Triamcinolone Acetonide Cream USP), 0.025%, 0.1%, 0.5%
0316-0170-022023-02-13C16284748780-1f386c649-b13d-0266-e053-dadaa90a7c1aTRIDERM (Triamcinolone Acetonide Cream USP), 0.025%, 0.1%, 0.5%
0316-0170-032023-02-13C16284748780-1f386c649-b13d-0266-e053-dadaa90a7c1aTRIDERM (Triamcinolone Acetonide Cream USP), 0.025%, 0.1%, 0.5%
0316-0170-032023-02-13C16284748780-1f386c649-b13d-0266-e053-dadaa90a7c1aTRIDERM (Triamcinolone Acetonide Cream USP), 0.025%, 0.1%, 0.5%
0316-0170-032023-02-13C16284748780-1f386c649-b13d-0266-e053-dadaa90a7c1aTRIDERM (Triamcinolone Acetonide Cream USP), 0.025%, 0.1%, 0.5%
0316-0170-012023-01-30C16284748780-1f386c649-b13d-0266-e053-dadaa90a7c1aTRIDERM (Triamcinolone Acetonide Cream USP), 0.025%, 0.1%, 0.5%
0316-0170-012023-01-30C16284748780-1f386c649-b13d-0266-e053-dadaa90a7c1aTRIDERM (Triamcinolone Acetonide Cream USP), 0.025%, 0.1%, 0.5%
0316-0170-012023-01-30C16284748780-1f386c649-b13d-0266-e053-dadaa90a7c1aTRIDERM (Triamcinolone Acetonide Cream USP), 0.025%, 0.1%, 0.5%
0316-0170-022023-01-30C16284748780-1f386c649-b13d-0266-e053-dadaa90a7c1aTRIDERM (Triamcinolone Acetonide Cream USP), 0.025%, 0.1%, 0.5%
0316-0170-022023-01-30C16284748780-1f386c649-b13d-0266-e053-dadaa90a7c1aTRIDERM (Triamcinolone Acetonide Cream USP), 0.025%, 0.1%, 0.5%
0316-0170-022023-01-30C16284748780-1f386c649-b13d-0266-e053-dadaa90a7c1aTRIDERM (Triamcinolone Acetonide Cream USP), 0.025%, 0.1%, 0.5%
0316-0170-032023-01-30C16284748780-1f386c649-b13d-0266-e053-dadaa90a7c1aTRIDERM (Triamcinolone Acetonide Cream USP), 0.025%, 0.1%, 0.5%
0316-0170-032023-01-30C16284748780-1f386c649-b13d-0266-e053-dadaa90a7c1aTRIDERM (Triamcinolone Acetonide Cream USP), 0.025%, 0.1%, 0.5%
0316-0170-032023-01-30C16284748780-1f386c649-b13d-0266-e053-dadaa90a7c1aTRIDERM (Triamcinolone Acetonide Cream USP), 0.025%, 0.1%, 0.5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0316-0170-01TRIDERM28.4 g in 1 TUBECREAM28.426
0316-0170-01TRIDERM1 in 1 CARTONCREAM126
0316-0170-02TRIDERM3 g in 1 POUCHCREAM326
0316-0170-03TRIDERM85.2 g in 1 TUBECREAM85.226
0316-0170-03TRIDERM1 in 1 CARTONCREAM126

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0316-0170-01GM - Gram0316-01701f383a8b-e39b-4ab8-ac32-84311fc89acc12012-07-24
0316-0170-03GM - Gram0316-01702e97eb3f-bd70-4dd7-b1d6-b5d280cc607d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRIAMCINOLONE ACETONIDEACTIVE INGREDIENTF446C597KATRIDERM (TRIAMCINOLONE ACETONIDE) CREAM [CROWN LABORATORIES]11
TRIAMCINOLONE ACETONIDEACTIVE MOIETYF446C597KATRIDERM (TRIAMCINOLONE ACETONIDE) CREAM [CROWN LABORATORIES]11
CETYL PALMITATEINACTIVE INGREDIENT5ZA2S6B08XTRIDERM (TRIAMCINOLONE ACETONIDE) CREAM [CROWN LABORATORIES]11
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPTRIDERM (TRIAMCINOLONE ACETONIDE) CREAM [CROWN LABORATORIES]11
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4TRIDERM (TRIAMCINOLONE ACETONIDE) CREAM [CROWN LABORATORIES]11
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TRIDERM (TRIAMCINOLONE ACETONIDE) CREAM [CROWN LABORATORIES]11
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BTRIDERM (TRIAMCINOLONE ACETONIDE) CREAM [CROWN LABORATORIES]11
SORBITOLINACTIVE INGREDIENT506T60A25RTRIDERM (TRIAMCINOLONE ACETONIDE) CREAM [CROWN LABORATORIES]11
WATERINACTIVE INGREDIENT059QF0KO0RTRIDERM (TRIAMCINOLONE ACETONIDE) CREAM [CROWN LABORATORIES]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0316-0170TRIDERM (TRIAMCINOLONE ACETONIDE) CREAM [CROWN LABORATORIES]24Current NDC, Legacy NDC, 5 package rows20231025_2c7fee2c-6f57-4de4-8803-98c0b31b07c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1085644triamcinolone acetonide 0.025 % Topical CreamPSN2c7fee2c-6f57-4de4-8803-98c0b31b07c326
1014314triamcinolone acetonide 0.1 % Topical CreamPSN2c7fee2c-6f57-4de4-8803-98c0b31b07c326
1085686triamcinolone acetonide 0.5 % Topical CreamPSN2c7fee2c-6f57-4de4-8803-98c0b31b07c326
1648997Triderm 0.025 % Topical CreamPSN2c7fee2c-6f57-4de4-8803-98c0b31b07c326
1085773Triderm 0.1 % Topical CreamPSN2c7fee2c-6f57-4de4-8803-98c0b31b07c326
1648999Triderm 0.5 % Topical CreamPSN2c7fee2c-6f57-4de4-8803-98c0b31b07c326
1648997triamcinolone acetonide 0.25 MG/ML Topical Cream [Triderm]SBD2c7fee2c-6f57-4de4-8803-98c0b31b07c326
1085773triamcinolone acetonide 1 MG/ML Topical Cream [Triderm]SBD2c7fee2c-6f57-4de4-8803-98c0b31b07c326
1648999triamcinolone acetonide 5 MG/ML Topical Cream [Triderm]SBD2c7fee2c-6f57-4de4-8803-98c0b31b07c326
1085644triamcinolone acetonide 0.25 MG/ML Topical CreamSCD2c7fee2c-6f57-4de4-8803-98c0b31b07c326
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCD2c7fee2c-6f57-4de4-8803-98c0b31b07c326
1085686triamcinolone acetonide 5 MG/ML Topical CreamSCD2c7fee2c-6f57-4de4-8803-98c0b31b07c326
1085644triamcinolone acetonide 0.025 % Topical CreamSY2c7fee2c-6f57-4de4-8803-98c0b31b07c326
1014314triamcinolone acetonide 0.1 % Topical CreamSY2c7fee2c-6f57-4de4-8803-98c0b31b07c326
1085686triamcinolone acetonide 0.5 % Topical CreamSY2c7fee2c-6f57-4de4-8803-98c0b31b07c326
1014314triamcinolone acetonide 1 MG per GM Topical CreamSY2c7fee2c-6f57-4de4-8803-98c0b31b07c326
1648997Triderm 0.025 % Topical CreamSY2c7fee2c-6f57-4de4-8803-98c0b31b07c326
1085773Triderm 0.1 % Topical CreamSY2c7fee2c-6f57-4de4-8803-98c0b31b07c326
1648997Triderm 0.25 MG/ML Topical CreamSY2c7fee2c-6f57-4de4-8803-98c0b31b07c326
1648999Triderm 0.5 % Topical CreamSY2c7fee2c-6f57-4de4-8803-98c0b31b07c326
1085773Triderm 1 MG/ML Topical CreamSY2c7fee2c-6f57-4de4-8803-98c0b31b07c326
1648999Triderm 5 MG/ML Topical CreamSY2c7fee2c-6f57-4de4-8803-98c0b31b07c326

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0316-0170-01003160170011 TUBE in 1 CARTON (0316-0170-01) / 28.4 g in 1 TUBE1 tube1984-03-190000-00-00NoNoCurrent
0316-0170-02003160170023 g in 1 POUCH (0316-0170-02) 3 g2007-11-200000-00-00YesNoCurrent
0316-0170-03003160170031 TUBE in 1 CARTON (0316-0170-03) / 85.2 g in 1 TUBE1 tube1984-03-190000-00-00NoNoCurrent