clindamycin phosphate

Product NDC
0168-0202
11-digit product format
001680202
Labeler code
0168
Product ID
0168-0202_cb48e014-0b84-4c84-867e-50c0f698340d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clindamycin phosphate
Dosage form
GEL
Route
TOPICAL
Labeler
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
Application
ANDA064160
Marketing category
ANDA
Marketing start
2000-01-28
Substance
CLINDAMYCIN PHOSPHATE
Active strength
10 mg/g
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]
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 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
A064160-001CLINDAMYCIN PHOSPHATECLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A064160-001AB1

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 06:07:402026-07A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB2000-01-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB2000-01-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB2000-01-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB2000-01-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB2000-01-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB2000-01-283f01610625f2…
2019-09-15 20:21 UTC2019-09A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB2000-01-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB2000-01-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-28e64feba35796…

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 06:07:402026-07A064160-001AB11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A064160-001AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064160-001AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A064160-001AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064160-001AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064160-001AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064160-001AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064160-001AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064160-001AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064160-001AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A064160-001AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064160-001AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064160-001AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064160-001AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A064160-001AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064160-001AB115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064160-001AB115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064160-001AB114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064160-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064160-001AB11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064160-001AB11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A064160-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A064160-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A064160-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A064160-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A064160-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A064160-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A064160-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A064160-001AB116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A064160-001AB111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A064160-001AB11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A064160-001AB11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A064160-001AB119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A064160-001AB11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A064160-001AB113f0d92c62455…
2023-05-13 08:27 UTC2023-05A064160-001AB11053a50430f4f…
2023-01-26 05:58 UTC2023-01A064160-001AB113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A064160-001AB113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A064160-001AB11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A064160-001AB11e64feba35796…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLINDAMYCIN PHOSPHATE10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
EH6D7113I8Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197519Internal RxNorm lookup
309333Internal RxNorm lookup
2676585Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
62a2019f-7410-4251-95ed-181925ade6e4Available 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
e3af9708-3004-7392-4046-5311eaa8bab5Product name320221128
ffb4bacf-f636-0f7d-0b0d-7a4b151243e3Product name920220928
b72227d6-0388-43bd-995b-b762d2754cd5Product name120220706
a92d22e0-3af4-f301-bc88-27ff030b0070Product name220220316
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
5ce6ce33-4f2b-3ce0-757d-e520013280cfProduct name520180719
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
0168-0202-30clindamycin phosphate1 in 1 CARTONGEL119
0168-0202-30clindamycin phosphate30 g in 1 TUBEGEL3019
0168-0202-60clindamycin phosphate1 in 1 CARTONGEL119
0168-0202-60clindamycin phosphate60 g in 1 TUBEGEL6019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0202-30GM - Gram0168-020240c4e1e8-c9f9-45bb-b04d-20cc46d4f70512012-07-24
0168-0202-60GM - Gram0168-020230128843-af42-40e4-b37d-53715497e2f612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLINDAMYCIN PHOSPHATEACTIVE INGREDIENTEH6D7113I8CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]8
CLINDAMYCINACTIVE MOIETY3U02EL437CCLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]8
ALLANTOININACTIVE INGREDIENT344S277G0ZCLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]8
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENTHHT01ZNK31CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]8
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SCLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]8
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]8
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]8
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]8
ISOSTEARYL ALCOHOLINACTIVE INGREDIENTQ613OCQ44YCLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]8
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]8
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]8
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]8
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]8
SODIUM LAUROYL SARCOSINATEINACTIVE INGREDIENT632GS99618CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]8
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]8
WATERINACTIVE INGREDIENT059QF0KO0RCLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]8
CLINDAMYCIN PHOSPHATEACTIVE INGREDIENTEH6D7113I8CLINDAMYCIN PHOSPHATE GEL [PREFERRED PHARMACEUTICALS, INC.]2
CLINDAMYCINACTIVE MOIETY3U02EL437CCLINDAMYCIN PHOSPHATE GEL [PREFERRED PHARMACEUTICALS, INC.]2
ALLANTOININACTIVE INGREDIENT344S277G0ZCLINDAMYCIN PHOSPHATE GEL [PREFERRED PHARMACEUTICALS, INC.]2
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENTHHT01ZNK31CLINDAMYCIN PHOSPHATE GEL [PREFERRED PHARMACEUTICALS, INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCLINDAMYCIN PHOSPHATE GEL [PREFERRED PHARMACEUTICALS, INC.]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCLINDAMYCIN PHOSPHATE GEL [PREFERRED PHARMACEUTICALS, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CLINDAMYCIN PHOSPHATE GEL [PREFERRED PHARMACEUTICALS, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICLINDAMYCIN PHOSPHATE GEL [PREFERRED PHARMACEUTICALS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RCLINDAMYCIN PHOSPHATE GEL [PREFERRED PHARMACEUTICALS, INC.]2
CLINDAMYCIN PHOSPHATEACTIVE INGREDIENTEH6D7113I8CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [PHYSICIANS TOTAL CARE, INC.]1
CLINDAMYCINACTIVE MOIETY3U02EL437CCLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [PHYSICIANS TOTAL CARE, INC.]1
ALLANTOININACTIVE INGREDIENT344S277G0ZCLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [PHYSICIANS TOTAL CARE, INC.]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SCLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [PHYSICIANS TOTAL CARE, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [PHYSICIANS TOTAL CARE, INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [PHYSICIANS TOTAL CARE, INC.]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [PHYSICIANS TOTAL CARE, INC.]1
ISOSTEARYL ALCOHOLINACTIVE INGREDIENTQ613OCQ44YCLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [PHYSICIANS TOTAL CARE, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [PHYSICIANS TOTAL CARE, INC.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [PHYSICIANS TOTAL CARE, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [PHYSICIANS TOTAL CARE, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RCLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0168-0202CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]17Current NDC, Legacy NDC, 4 package rows20220303_62a2019f-7410-4251-95ed-181925ade6e4.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
clindamycin phosphateCLINDAMYCIN PHOSPHATEE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC62a2019f-7410-4251-95ed-181925ade6e42026-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064160
application number: ANDA064160
ndc (product): 0168-0202

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197519clindamycin phosphate 1 % Topical LotionPSN62a2019f-7410-4251-95ed-181925ade6e419
309333clindamycin phosphate 1 % Topical SolutionPSN62a2019f-7410-4251-95ed-181925ade6e419
2676585clindamycin phosphate 1 % Twice-Daily Topical GelPSN62a2019f-7410-4251-95ed-181925ade6e419
197519clindamycin 10 MG/ML Topical LotionSCD62a2019f-7410-4251-95ed-181925ade6e419
309333clindamycin 10 MG/ML Topical SolutionSCD62a2019f-7410-4251-95ed-181925ade6e419
2676585Twice-Daily clindamycin 0.01 MG/MG Topical GelSCD62a2019f-7410-4251-95ed-181925ade6e419
197519clindamycin (as clindamycin phosphate) 1 % Topical LotionSY62a2019f-7410-4251-95ed-181925ade6e419
309333clindamycin (as clindamycin phosphate) 1 % Topical SolutionSY62a2019f-7410-4251-95ed-181925ade6e419
2676585clindamycin (as clindamycin phosphate) 1 % Twice-Daily Topical GelSY62a2019f-7410-4251-95ed-181925ade6e419
197519clindamycin 1 % Topical LotionSY62a2019f-7410-4251-95ed-181925ade6e419
309333clindamycin 1 % Topical SolutionSY62a2019f-7410-4251-95ed-181925ade6e419
2676585clindamycin phosphate 1 % Twice-Daily Topical GelPSNe0a0221d-f1fc-470c-8646-8da33c815b8a15
2676585Twice-Daily clindamycin 0.01 MG/MG Topical GelSCDe0a0221d-f1fc-470c-8646-8da33c815b8a15
2676585clindamycin (as clindamycin phosphate) 1 % Twice-Daily Topical GelSYe0a0221d-f1fc-470c-8646-8da33c815b8a15
197519clindamycin phosphate 1 % Topical LotionPSNf93faee5-589b-4508-a56f-bcf0b39277601
309333clindamycin phosphate 1 % Topical SolutionPSNf93faee5-589b-4508-a56f-bcf0b39277601
2676585clindamycin phosphate 1 % Twice-Daily Topical GelPSNf93faee5-589b-4508-a56f-bcf0b39277601
197519clindamycin 10 MG/ML Topical LotionSCDf93faee5-589b-4508-a56f-bcf0b39277601
309333clindamycin 10 MG/ML Topical SolutionSCDf93faee5-589b-4508-a56f-bcf0b39277601
2676585Twice-Daily clindamycin 0.01 MG/MG Topical GelSCDf93faee5-589b-4508-a56f-bcf0b39277601
197519clindamycin (as clindamycin phosphate) 1 % Topical LotionSYf93faee5-589b-4508-a56f-bcf0b39277601
309333clindamycin (as clindamycin phosphate) 1 % Topical SolutionSYf93faee5-589b-4508-a56f-bcf0b39277601
2676585clindamycin (as clindamycin phosphate) 1 % Twice-Daily Topical GelSYf93faee5-589b-4508-a56f-bcf0b39277601
197519clindamycin 1 % Topical LotionSYf93faee5-589b-4508-a56f-bcf0b39277601
309333clindamycin 1 % Topical SolutionSYf93faee5-589b-4508-a56f-bcf0b39277601

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0168-0202-30001680202301 TUBE in 1 CARTON (0168-0202-30) / 30 g in 1 TUBE1 tube2000-01-280000-00-00NoNoCurrent
0168-0202-60001680202601 TUBE in 1 CARTON (0168-0202-60) / 60 g in 1 TUBE1 tube2000-01-280000-00-00NoNoCurrent