clindamycin phosphate

Product NDC: 0168-0201
11-digit product format: 001680201
Labeler code: 0168
Product ID: 0168-0201_cb48e014-0b84-4c84-867e-50c0f698340d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clindamycin phosphate
Dosage form: SOLUTION
Route: TOPICAL
Labeler: E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
Application: ANDA064159
Marketing category: ANDA
Marketing start: 1997-06-05
Substance: CLINDAMYCIN PHOSPHATE
Active strength: 10 mg/mL
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLINDAMYCIN PHOSPHATE	10 mg/mL

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	EH6D7113I8
Rxcui	197519, 309333, 2676585

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a46239a7-5963-4008-8cbb-6b9000f497eb	Product name	1	20250721
1426d8f8-b7d5-4053-8554-613df00c0d86	Product name	2	20250616
b382b4e1-6b48-45f6-bffc-e61b00b0ce19	Product name	3	20250317
d8f81258-db12-0761-46cc-8ff6e62e9302	Product name	4	20240422
b7b2fa42-1c77-d724-81f0-87da60a77e79	Product name	3	20240320
b27c7c65-51f2-a62f-e0e6-a26b3a0f8eb0	Product name	3	20230425
e3af9708-3004-7392-4046-5311eaa8bab5	Product name	3	20221128
ffb4bacf-f636-0f7d-0b0d-7a4b151243e3	Product name	9	20220928
b72227d6-0388-43bd-995b-b762d2754cd5	Product name	1	20220706
a92d22e0-3af4-f301-bc88-27ff030b0070	Product name	2	20220316
4a7d44fe-774d-404b-aad0-8a90fe78375a	Product name	4	20211025
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27b	Product name	3	20200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992	Product name	4	20190619
5ce6ce33-4f2b-3ce0-757d-e520013280cf	Product name	5	20180719
b92a26f1-6926-4817-be73-e26ab4c2146f	Product name	1	20170602
028d6c95-5012-6976-2075-dee0ae6fefe2	Product name	1	20140508
468b2c08-8adb-8d0f-8257-c6515a061424	Product name	1	20140508
8959fb29-d86f-c521-666a-b4cb22233594	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0168-0201-30	clindamycin phosphate	1 in 1 CARTON	SOLUTION	1	19
0168-0201-30	clindamycin phosphate	30 mL in 1 BOTTLE	SOLUTION	30	19
0168-0201-60	clindamycin phosphate	60 mL in 1 BOTTLE	SOLUTION	60	19
0168-0201-60	clindamycin phosphate	1 in 1 CARTON	SOLUTION	1	19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0168-0201-30	ML - Milliliter	0168-0201	723e1a73-b487-449e-a4cb-96b93cc16445	1	2016-10-06
0168-0201-60	ML - Milliliter	0168-0201	9fa99f4b-f5a8-49d1-81a9-ef237a573ba5	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CLINDAMYCIN PHOSPHATE	ACTIVE INGREDIENT	EH6D7113I8	CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	8
CLINDAMYCIN	ACTIVE MOIETY	3U02EL437C	CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	8
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	CLINDAMYCIN 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 INGREDIENT	HHT01ZNK31	CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	8
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	8
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	8
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	8
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	8
ISOSTEARYL ALCOHOL	INACTIVE INGREDIENT	Q613OCQ44Y	CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	8
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	8
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	8
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	8
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	8
SODIUM LAUROYL SARCOSINATE	INACTIVE INGREDIENT	632GS99618	CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	8
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	8
WATER	INACTIVE INGREDIENT	059QF0KO0R	CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	8
CLINDAMYCIN PHOSPHATE	ACTIVE INGREDIENT	EH6D7113I8	CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [PHYSICIANS TOTAL CARE, INC.]	1
Clindamycin phosphate	ACTIVE INGREDIENT	EH6D7113I8	CLINDAMYCIN PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]	1
Clindamycin	ACTIVE MOIETY	3U02EL437C	CLINDAMYCIN PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]	1
CLINDAMYCIN	ACTIVE MOIETY	3U02EL437C	CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [PHYSICIANS TOTAL CARE, INC.]	1
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [PHYSICIANS TOTAL CARE, INC.]	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [PHYSICIANS TOTAL CARE, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [PHYSICIANS TOTAL CARE, INC.]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [PHYSICIANS TOTAL CARE, INC.]	1
isopropyl alcohol	INACTIVE INGREDIENT	ND2M416302	CLINDAMYCIN PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [PHYSICIANS TOTAL CARE, INC.]	1
ISOSTEARYL ALCOHOL	INACTIVE INGREDIENT	Q613OCQ44Y	CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [PHYSICIANS TOTAL CARE, INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [PHYSICIANS TOTAL CARE, INC.]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [PHYSICIANS TOTAL CARE, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [PHYSICIANS TOTAL CARE, INC.]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	CLINDAMYCIN PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [PHYSICIANS TOTAL CARE, INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	CLINDAMYCIN PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [PHYSICIANS TOTAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0168-0201	CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	17	Current NDC, Legacy NDC, 4 package rows	20220303_62a2019f-7410-4251-95ed-181925ade6e4.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
EH6D7113I8	CLINDAMYCIN PHOSPHATE	24729-96-2	CLINDAMYCIN PHOSPHATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197519	clindamycin phosphate 1 % Topical Lotion	PSN	62a2019f-7410-4251-95ed-181925ade6e4	19
309333	clindamycin phosphate 1 % Topical Solution	PSN	62a2019f-7410-4251-95ed-181925ade6e4	19
2676585	clindamycin phosphate 1 % Twice-Daily Topical Gel	PSN	62a2019f-7410-4251-95ed-181925ade6e4	19
197519	clindamycin 10 MG/ML Topical Lotion	SCD	62a2019f-7410-4251-95ed-181925ade6e4	19
309333	clindamycin 10 MG/ML Topical Solution	SCD	62a2019f-7410-4251-95ed-181925ade6e4	19
2676585	Twice-Daily clindamycin 0.01 MG/MG Topical Gel	SCD	62a2019f-7410-4251-95ed-181925ade6e4	19
197519	clindamycin (as clindamycin phosphate) 1 % Topical Lotion	SY	62a2019f-7410-4251-95ed-181925ade6e4	19
309333	clindamycin (as clindamycin phosphate) 1 % Topical Solution	SY	62a2019f-7410-4251-95ed-181925ade6e4	19
2676585	clindamycin (as clindamycin phosphate) 1 % Twice-Daily Topical Gel	SY	62a2019f-7410-4251-95ed-181925ade6e4	19
197519	clindamycin 1 % Topical Lotion	SY	62a2019f-7410-4251-95ed-181925ade6e4	19
309333	clindamycin 1 % Topical Solution	SY	62a2019f-7410-4251-95ed-181925ade6e4	19
197519	clindamycin phosphate 1 % Topical Lotion	PSN	f93faee5-589b-4508-a56f-bcf0b3927760	1
309333	clindamycin phosphate 1 % Topical Solution	PSN	f93faee5-589b-4508-a56f-bcf0b3927760	1
309333	clindamycin phosphate 1 % Topical Solution	PSN	fdd0e957-a600-40a3-b9c7-2b0fd98a5b12	1
2676585	clindamycin phosphate 1 % Twice-Daily Topical Gel	PSN	f93faee5-589b-4508-a56f-bcf0b3927760	1
197519	clindamycin 10 MG/ML Topical Lotion	SCD	f93faee5-589b-4508-a56f-bcf0b3927760	1
309333	clindamycin 10 MG/ML Topical Solution	SCD	fdd0e957-a600-40a3-b9c7-2b0fd98a5b12	1
309333	clindamycin 10 MG/ML Topical Solution	SCD	f93faee5-589b-4508-a56f-bcf0b3927760	1
2676585	Twice-Daily clindamycin 0.01 MG/MG Topical Gel	SCD	f93faee5-589b-4508-a56f-bcf0b3927760	1
197519	clindamycin (as clindamycin phosphate) 1 % Topical Lotion	SY	f93faee5-589b-4508-a56f-bcf0b3927760	1
309333	clindamycin (as clindamycin phosphate) 1 % Topical Solution	SY	f93faee5-589b-4508-a56f-bcf0b3927760	1
309333	clindamycin (as clindamycin phosphate) 1 % Topical Solution	SY	fdd0e957-a600-40a3-b9c7-2b0fd98a5b12	1
2676585	clindamycin (as clindamycin phosphate) 1 % Twice-Daily Topical Gel	SY	f93faee5-589b-4508-a56f-bcf0b3927760	1
197519	clindamycin 1 % Topical Lotion	SY	f93faee5-589b-4508-a56f-bcf0b3927760	1
309333	clindamycin 1 % Topical Solution	SY	f93faee5-589b-4508-a56f-bcf0b3927760	1
309333	clindamycin 1 % Topical Solution	SY	fdd0e957-a600-40a3-b9c7-2b0fd98a5b12	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0168-0201-30	00168020130	1 BOTTLE in 1 CARTON (0168-0201-30) / 30 mL in 1 BOTTLE	1 bottle	1997-06-05	0000-00-00	No	No	Current
0168-0201-60	00168020160	1 BOTTLE in 1 CARTON (0168-0201-60) / 60 mL in 1 BOTTLE	1 bottle	1997-06-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clindamycin Phosphate Topical Solution USP, 1%, Clindamycin Phosphate Gel USP, 1%, Clindamycin Phosphate Topical Lotion, 1%	E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC	2026-01-28	HUMAN PRESCRIPTION DRUG LABEL	19
CLINDAMYCIN PHOSPHATE PLEDGETS 1% (CLINDAMYCIN PHOSPHATE TOPICAL SOLUTION USP, 1%)	Rebel Distributors Corp	2010-09-23	HUMAN PRESCRIPTION DRUG LABEL	1
clindamycin phosphate	Physicians Total Care, Inc.	2010-02-12	HUMAN PRESCRIPTION DRUG LABEL	1

clindamycin phosphate

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#