clindamycin and benzoyl peroxide

Product NDC
45802-509
11-digit product format
458020509
Labeler code
45802
Product ID
45802-509_bae79e41-1b56-4bcc-9635-ffcf85fa0fde
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clindamycin and benzoyl peroxide
Dosage form
KIT
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA202440
Marketing category
ANDA
Marketing start
2021-02-03
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202440-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEBENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE5%;EQ 1% BASEGEL / TOPICALAB2015-09-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202440-001AB

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A202440-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE5%;EQ 1% BASEGEL / TOPICALAB2015-09-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202440-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE5%;EQ 1% BASEGEL / TOPICALAB2015-09-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202440-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE5%;EQ 1% BASEGEL / TOPICALAB2015-09-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202440-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE5%;EQ 1% BASEGEL / TOPICALAB2015-09-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202440-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE5%;EQ 1% BASEGEL / TOPICALAB2015-09-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202440-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE5%;EQ 1% BASEGEL / TOPICALAB2015-09-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202440-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE5%;EQ 1% BASEGEL / TOPICALAB2015-09-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202440-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE5%;EQ 1% BASEGEL / TOPICALAB2015-09-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202440-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE5%;EQ 1% BASEGEL / TOPICALAB2015-09-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202440-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE5%;EQ 1% BASEGEL / TOPICALAB2015-09-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202440-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE5%;EQ 1% BASEGEL / TOPICALAB2015-09-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202440-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE5%;EQ 1% BASEGEL / TOPICALAB2015-09-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202440-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE5%;EQ 1% BASEGEL / TOPICALAB2015-09-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202440-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE5%;EQ 1% BASEGEL / TOPICALAB2015-09-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202440-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE5%;EQ 1% BASEGEL / TOPICALAB2015-09-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202440-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE5%;EQ 1% BASEGEL / TOPICALAB2015-09-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202440-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE5%;EQ 1% BASEGEL / TOPICALAB2015-09-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202440-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE5%;EQ 1% BASEGEL / TOPICALAB2015-09-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202440-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE5%;EQ 1% BASEGEL / TOPICALAB2015-09-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202440-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE5%;EQ 1% BASEGEL / TOPICALAB2015-09-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202440-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE5%;EQ 1% BASEGEL / TOPICALAB2015-09-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202440-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE5%;EQ 1% BASEGEL / TOPICALAB2015-09-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A202440-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE5%;EQ 1% BASEGEL / TOPICALAB2015-09-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202440-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE5%;EQ 1% BASEGEL / TOPICALAB2015-09-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202440-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE5%;EQ 1% BASEGEL / TOPICALAB2015-09-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202440-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE5%;EQ 1% BASEGEL / TOPICALAB2015-09-213f01610625f2…
2019-09-15 20:21 UTC2019-09A202440-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE5%;EQ 1% BASEGEL / TOPICALAB2015-09-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A202440-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE5%;EQ 1% BASEGEL / TOPICALAB2015-09-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202440-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE5%;EQ 1% BASEGEL / TOPICALAB2015-09-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202440-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE5%;EQ 1% BASEGEL / TOPICALAB2015-09-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202440-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE5%;EQ 1% BASEGEL / TOPICALAB2015-09-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202440-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE5%;EQ 1% BASEGEL / TOPICALAB2015-09-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202440-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE5%;EQ 1% BASEGEL / TOPICALAB2015-09-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202440-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE5%;EQ 1% BASEGEL / TOPICALAB2015-09-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202440-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE5%;EQ 1% BASEGEL / TOPICALAB2015-09-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A202440-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE5%;EQ 1% BASEGEL / TOPICALAB2015-09-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A202440-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE5%;EQ 1% BASEGEL / TOPICALAB2015-09-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202440-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE5%;EQ 1% BASEGEL / TOPICALAB2015-09-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202440-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE5%;EQ 1% BASEGEL / TOPICALAB2015-09-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202440-001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE5%;EQ 1% BASEGEL / TOPICALAB2015-09-21e64feba35796…

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 06:07:402026-07A202440-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202440-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202440-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202440-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202440-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202440-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202440-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202440-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202440-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202440-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202440-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202440-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202440-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202440-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202440-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202440-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202440-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202440-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202440-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202440-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202440-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202440-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A202440-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202440-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202440-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202440-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A202440-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A202440-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202440-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202440-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202440-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202440-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202440-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202440-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202440-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A202440-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A202440-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202440-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202440-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202440-001AB1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
clindamycin and benzoyl peroxide
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308694Internal RxNorm lookup
358917Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f5e0ce64-605d-487c-a7b9-c00457925d94Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
1426d8f8-b7d5-4053-8554-613df00c0d86Product name220250616
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d8f81258-db12-0761-46cc-8ff6e62e9302Product name420240422
b7b2fa42-1c77-d724-81f0-87da60a77e79Product name320240320
b27c7c65-51f2-a62f-e0e6-a26b3a0f8eb0Product name320230425
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
e3af9708-3004-7392-4046-5311eaa8bab5Product name320221128
ffb4bacf-f636-0f7d-0b0d-7a4b151243e3Product name920220928
b72227d6-0388-43bd-995b-b762d2754cd5Product name120220706
a92d22e0-3af4-f301-bc88-27ff030b0070Product name220220316
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
5ce6ce33-4f2b-3ce0-757d-e520013280cfProduct name520180719
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
b92a26f1-6926-4817-be73-e26ab4c2146fProduct name120170602
028d6c95-5012-6976-2075-dee0ae6fefe2Product name120140508
468b2c08-8adb-8d0f-8257-c6515a061424Product name120140508
8959fb29-d86f-c521-666a-b4cb22233594Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-509-01clindamycin and benzoyl peroxide1 in 1 CARTONKIT14
45802-737-01clindamycin and benzoyl peroxide0.3 g in 1 VIALPOWDER, FOR SOLUTION0.3 g10 mg in 1g4
45802-997-01clindamycin and benzoyl peroxide19.7 g in 1 JARGEL19.7 g50 mg in 1g4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-509-01GM - Gram45802-509eeec71b1-576b-404c-9230-597caf02841012021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-509CLINDAMYCIN AND BENZOYL PEROXIDE KIT [PADAGIS ISRAEL PHARMACEUTICALS LTD]4Current NDC, Legacy NDC, 3 package rows20231011_f5e0ce64-605d-487c-a7b9-c00457925d94.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLINDAMYCIN AND BENZOYL PEROXIDECLINDAMYCIN AND BENZOYL PEROXIDEBryant Ranch Prepack30d311b4-9058-4ebf-898e-17ba662945002023-08-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202440
application number: ANDA202440
CLINDAMYCIN AND BENZOYL PEROXIDECLINDAMYCIN AND BENZOYL PEROXIDEPadagis Israel Pharmaceuticals Ltd9cba4e83-64b0-43b6-a337-cd0fd4744d312022-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202440
application number: ANDA202440
clindamycin and benzoyl peroxideCLINDAMYCIN AND BENZOYL PEROXIDEPadagis Israel Pharmaceuticals Ltd1144d82f-085c-45a4-b32d-9b24c495d1542022-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202440
application number: ANDA202440
clindamycin and benzoyl peroxideCLINDAMYCIN AND BENZOYL PEROXIDEPadagis Israel Pharmaceuticals Ltd6bf0f3e5-6ad7-4791-9483-0977b18ad77f2022-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202440
application number: ANDA202440
clindamycin and benzoyl peroxideCLINDAMYCIN AND BENZOYL PEROXIDEPadagis Israel Pharmaceuticals Ltdf5e0ce64-605d-487c-a7b9-c00457925d942022-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202440
application number: ANDA202440
ndc (product): 45802-509

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308694benzoyl peroxide 5 % Topical GelPSNf5e0ce64-605d-487c-a7b9-c00457925d944
358917clindamycin phosphate 1 % / benzoyl peroxide 5 % Topical GelPSNf5e0ce64-605d-487c-a7b9-c00457925d944
358917benzoyl peroxide 0.05 MG/MG / clindamycin 0.01 MG/MG Topical GelSCDf5e0ce64-605d-487c-a7b9-c00457925d944
308694benzoyl peroxide 0.05 MG/MG Topical GelSCDf5e0ce64-605d-487c-a7b9-c00457925d944
358917benzoyl peroxide 5 % / clindamycin 1 % (as clindamycin phosphate 1.2 % ) Topical GelSYf5e0ce64-605d-487c-a7b9-c00457925d944
358917benzoyl peroxide 5 % / clindamycin 1 % Topical GelSYf5e0ce64-605d-487c-a7b9-c00457925d944
308694benzoyl peroxide 5 % Topical GelSYf5e0ce64-605d-487c-a7b9-c00457925d944

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-509-01458020509011 KIT in 1 CARTON (45802-509-01) * .3 g in 1 VIAL (45802-737-01) * 19.7 g in 1 JAR (45802-997-01) 1 kit2021-02-030000-00-00NoNoCurrent
45802-737-01458020737010.3 g in 1 VIAL0.3 gHistorical
45802-997-014580209970119.7 g in 1 JAR19.7 gHistorical