Condylox

Product NDC
0023-6118
11-digit product format
000236118
Labeler code
0023
Product ID
0023-6118_9f2892be-8330-4fd1-930e-b4d204df4e03
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
podofilox
Dosage form
GEL
Route
TOPICAL
Labeler
Allergan, Inc.
Application
NDA020529
Marketing category
NDA
Marketing start
1997-03-13
Marketing end
2026-10-31
Substance
PODOFILOX
Active strength
5 mg/g
Pharmacologic classes
Decreased Mitosis [PE]
NDC exclude flag
No
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
N020529-001CONDYLOXPODOFILOX0.5%GEL / TOPICALRLD1997-03-13

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 UTC2026-02N020529-001CONDYLOX0.5%GEL / TOPICALRLD1997-03-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020529-001CONDYLOX0.5%GEL / TOPICALABRLD, RS1997-03-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08N020529-001CONDYLOX0.5%GEL / TOPICALABRLD, RS1997-03-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020529-001CONDYLOX0.5%GEL / TOPICALABRLD, RS1997-03-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020529-001CONDYLOX0.5%GEL / TOPICALABRLD, RS1997-03-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020529-001CONDYLOX0.5%GEL / TOPICALABRLD, RS1997-03-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020529-001CONDYLOX0.5%GEL / TOPICALABRLD, RS1997-03-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020529-001CONDYLOX0.5%GEL / TOPICALABRLD, RS1997-03-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020529-001CONDYLOX0.5%GEL / TOPICALABRLD, RS1997-03-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020529-001CONDYLOX0.5%GEL / TOPICALABRLD, RS1997-03-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020529-001CONDYLOX0.5%GEL / TOPICALABRLD, RS1997-03-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020529-001CONDYLOX0.5%GEL / TOPICALABRLD, RS1997-03-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020529-001CONDYLOX0.5%GEL / TOPICALABRLD, RS1997-03-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020529-001CONDYLOX0.5%GEL / TOPICALABRLD, RS1997-03-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020529-001CONDYLOX0.5%GEL / TOPICALRLD, RS1997-03-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020529-001CONDYLOX0.5%GEL / TOPICALRLD, RS1997-03-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020529-001CONDYLOX0.5%GEL / TOPICALRLD, RS1997-03-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020529-001CONDYLOX0.5%GEL / TOPICALRLD, RS1997-03-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020529-001CONDYLOX0.5%GEL / TOPICALRLD, RS1997-03-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020529-001CONDYLOX0.5%GEL / TOPICALRLD, RS1997-03-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020529-001CONDYLOX0.5%GEL / TOPICALRLD, RS1997-03-1387673890dc5c…
2021-03-12 10:30 UTC2021-03N020529-001CONDYLOX0.5%GEL / TOPICALRLD, RS1997-03-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020529-001CONDYLOX0.5%GEL / TOPICALRLD, RS1997-03-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020529-001CONDYLOX0.5%GEL / TOPICALRLD, RS1997-03-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020529-001CONDYLOX0.5%GEL / TOPICALRLD, RS1997-03-133f01610625f2…
2019-09-15 20:21 UTC2019-09N020529-001CONDYLOX0.5%GEL / TOPICALRLD, RS1997-03-13b00525d2431f…
2019-07-19 19:46 UTC2019-07N020529-001CONDYLOX0.5%GEL / TOPICALRLD, RS1997-03-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020529-001CONDYLOX0.5%GEL / TOPICALABRLD, RS1997-03-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020529-001CONDYLOX0.5%GEL / TOPICALABRLD, RS1997-03-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020529-001CONDYLOX0.5%GEL / TOPICALABRLD, RS1997-03-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020529-001CONDYLOX0.5%GEL / TOPICALRLD, RS1997-03-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020529-001CONDYLOX0.5%GEL / TOPICALRLD, RS1997-03-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020529-001CONDYLOX0.5%GEL / TOPICALRLD, RS1997-03-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020529-001CONDYLOX0.5%GEL / TOPICALRLD, RS1997-03-133f0d92c62455…
2023-05-13 08:27 UTC2023-05N020529-001CONDYLOX0.5%GEL / TOPICALRLD, RS1997-03-13053a50430f4f…
2023-01-26 05:58 UTC2023-01N020529-001CONDYLOX0.5%GEL / TOPICALRLD, RS1997-03-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020529-001CONDYLOX0.5%GEL / TOPICALRLD, RS1997-03-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020529-001CONDYLOX0.5%GEL / TOPICALRLD, RS1997-03-13f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020529-001CONDYLOX0.5%GEL / TOPICALRLD, RS1997-03-13e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020529-001CONDYLOX0.5%GEL / TOPICALRLD, RS1997-03-13cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020529-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020529-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020529-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020529-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020529-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020529-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020529-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020529-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020529-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020529-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020529-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020529-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020529-001AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020529-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020529-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020529-001AB1ea1830bbd6c7…

Additional Listing Data#

Finished product
Yes
Brand name base
Condylox

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PODOFILOX5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L36H50F353Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312466Internal RxNorm lookup
351750Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
032e4bcb-b1ed-4029-b2a6-e92f3bf5cc37Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a90fd6c4-df39-45aa-ddf9-e6c34fff3951Product name220250805
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
22fe7b8d-6b80-a6ee-3b72-558f5763c606Product name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0023-6118-03Condylox3.5 g in 1 TUBE, WITH APPLICATORGEL3.58

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-6118-03GM - Gram0023-6118ca0a495a-a8f2-403d-8a22-4b49ab0885d712018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0023-6118CONDYLOX (PODOFILOX) GEL [ALLERGAN, INC.]7Current NDC, Legacy NDC, 1 package rows20241109_032e4bcb-b1ed-4029-b2a6-e92f3bf5cc37.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CondyloxPODOFILOXAllergan, Inc.032e4bcb-b1ed-4029-b2a6-e92f3bf5cc372024-01-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 020529
application number: NDA020529
ndc (product): 0023-6118

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351750Condylox 0.5 % Topical GelPSN032e4bcb-b1ed-4029-b2a6-e92f3bf5cc378
312466podofilox 0.5 % Topical GelPSN032e4bcb-b1ed-4029-b2a6-e92f3bf5cc378
351750podofilox 0.005 MG/MG Topical Gel [Condylox]SBD032e4bcb-b1ed-4029-b2a6-e92f3bf5cc378
312466podofilox 0.005 MG/MG Topical GelSCD032e4bcb-b1ed-4029-b2a6-e92f3bf5cc378
351750Condylox (podofilox 0.005 MG/MG) Topical GelSY032e4bcb-b1ed-4029-b2a6-e92f3bf5cc378
351750Condylox 0.5 % Topical GelSY032e4bcb-b1ed-4029-b2a6-e92f3bf5cc378
312466podophyllotoxin 0.5 % Topical GelSY032e4bcb-b1ed-4029-b2a6-e92f3bf5cc378

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0023-6118-03000236118033.5 g in 1 TUBE, WITH APPLICATOR (0023-6118-03) 3.5 g1997-03-132026-10-31NoNoCurrent