FDA.reportPublic FDA data

Keralyt

Product NDC
11086-030
11-digit product format
110860030
Labeler code
11086
Product ID
11086-030_521a893e-bafa-ccfa-e063-6294a90a6119
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
salicylic acid
Dosage form
GEL
Route
TOPICAL
Labeler
Summers Laboratories Inc
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2009-11-01
Substance
SALICYLIC ACID
Active strength
6 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID6 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO414PZ4LPZ
Rxcui212332, 312893

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11086-030-102026-01-29C16284748780-149896155-a5a0-586f-e063-e6dba90add90Summers Laboratories (as PLD) - Keralyt Gel (Salicylic Acid) 6% (11086-030)
11086-030-602026-01-29C16284748780-149896155-a5a0-586f-e063-e6dba90add90Summers Laboratories (as PLD) - Keralyt Gel (Salicylic Acid) 6% (11086-030)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11086-030-10Keralyt100 g in 1 TUBEGEL10024
11086-030-60Keralyt60 g in 1 BOTTLE, WITH APPLICATORGEL6024
11086-030-60Keralyt60 g in 1 BOTTLE, WITH APPLICATORGEL1 g6 g in 100g16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11086-030-10GM - Gram11086-03095be68b9-7587-4adf-ab31-9a75d1049e7012013-06-04
11086-030-40GM - Gram11086-03015c585ea-f4ce-4b91-ae37-f89b567fc98b12013-06-04
11086-030-60GM - Gram11086-030f8c76fa4-db50-428b-bcff-4b24cf264c2012021-03-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZKERALYT (SALICYLIC ACID) GEL [SUMMERS LABORATORIES INC]15
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZKERALYT (SALICYLIC ACID) GEL [SUMMERS LABORATORIES INC]15
ALCOHOLINACTIVE INGREDIENT3K9958V90MKERALYT (SALICYLIC ACID) GEL [SUMMERS LABORATORIES INC]15
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PKERALYT (SALICYLIC ACID) GEL [SUMMERS LABORATORIES INC]15
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3KERALYT (SALICYLIC ACID) GEL [SUMMERS LABORATORIES INC]15
WATERINACTIVE INGREDIENT059QF0KO0RKERALYT (SALICYLIC ACID) GEL [SUMMERS LABORATORIES INC]15
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZKERALYT (SALICYLIC ACID) KIT [SUMMERS LABORATORIES INC]10
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZKERALYT (SALICYLIC ACID) KIT [SUMMERS LABORATORIES INC]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11086-030KERALYT (SALICYLIC ACID) GEL [SUMMERS LABORATORIES INC]22Current NDC, Legacy NDC, 2 package rows20240328_8195e4e0-b812-11de-81b4-0002a5d5c51b.zip
11086-030KERALYT (SALICYLIC ACID) KIT [SUMMERS LABORATORIES INC]16Current NDC, Legacy NDC20231010_79bff5e0-bccb-11de-b462-0002a5d5c51b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
212332Keralyt 6 % Topical GelPSN8195e4e0-b812-11de-81b4-0002a5d5c51b24
312893salicylic acid 6 % Topical GelPSN8195e4e0-b812-11de-81b4-0002a5d5c51b24
212332salicylic acid 0.06 MG/MG Topical Gel [Keralyt]SBD8195e4e0-b812-11de-81b4-0002a5d5c51b24
312893salicylic acid 0.06 MG/MG Topical GelSCD8195e4e0-b812-11de-81b4-0002a5d5c51b24
212332Keralyt 0.06 MG/MG Topical GelSY8195e4e0-b812-11de-81b4-0002a5d5c51b24
212332Keralyt 6 % Topical GelSY8195e4e0-b812-11de-81b4-0002a5d5c51b24
312893salicylic acid 6 % Topical GelSY8195e4e0-b812-11de-81b4-0002a5d5c51b24
883501{1 (60000 MG) (salicylic acid 0.06 MG/MG Topical Gel [Keralyt]) / 1 (160 ML) (salicylic acid 60 MG/ML Medicated Shampoo [Keralyt]) } Pack [Keralyt Scalp]BPCK79bff5e0-bccb-11de-b462-0002a5d5c51b16
866892{1 (60000 MG) (salicylic acid 0.06 MG/MG Topical Gel) / 1 (160 ML) (salicylic acid 60 MG/ML Medicated Shampoo) } PackGPCK79bff5e0-bccb-11de-b462-0002a5d5c51b16
999618Keralyt 6 % Medicated ShampooPSN79bff5e0-bccb-11de-b462-0002a5d5c51b16
883501Keralyt 6 % Scalp Complete KitPSN79bff5e0-bccb-11de-b462-0002a5d5c51b16
212332Keralyt 6 % Topical GelPSN79bff5e0-bccb-11de-b462-0002a5d5c51b16
667904salicylic acid 6 % Medicated ShampooPSN79bff5e0-bccb-11de-b462-0002a5d5c51b16
866892salicylic acid 6 % Medicated Shampoo (160 ML) / salicylic acid 6 % Topical Gel (60000 MG) PackPSN79bff5e0-bccb-11de-b462-0002a5d5c51b16
312893salicylic acid 6 % Topical GelPSN79bff5e0-bccb-11de-b462-0002a5d5c51b16
212332salicylic acid 0.06 MG/MG Topical Gel [Keralyt]SBD79bff5e0-bccb-11de-b462-0002a5d5c51b16
999618salicylic acid 60 MG/ML Medicated Shampoo [Keralyt]SBD79bff5e0-bccb-11de-b462-0002a5d5c51b16
312893salicylic acid 0.06 MG/MG Topical GelSCD79bff5e0-bccb-11de-b462-0002a5d5c51b16
667904salicylic acid 60 MG/ML Medicated ShampooSCD79bff5e0-bccb-11de-b462-0002a5d5c51b16
866892{1 (160 ML Salicylic Acid 6 % Medicated Shampoo) / 1 (60000 MG Salicylic Acid 6 % Topical Gel) } PackSY79bff5e0-bccb-11de-b462-0002a5d5c51b16
212332Keralyt 0.06 MG/MG Topical GelSY79bff5e0-bccb-11de-b462-0002a5d5c51b16
999618Keralyt 6 % Medicated ShampooSY79bff5e0-bccb-11de-b462-0002a5d5c51b16
883501Keralyt 6 % Scalp Complete KitSY79bff5e0-bccb-11de-b462-0002a5d5c51b16
212332Keralyt 6 % Topical GelSY79bff5e0-bccb-11de-b462-0002a5d5c51b16
999618Keralyt 60 MG/ML Medicated ShampooSY79bff5e0-bccb-11de-b462-0002a5d5c51b16
667904salicylic acid 6 % Medicated ShampooSY79bff5e0-bccb-11de-b462-0002a5d5c51b16
312893salicylic acid 6 % Topical GelSY79bff5e0-bccb-11de-b462-0002a5d5c51b16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11086-030-1011086003010100 g in 1 TUBE (11086-030-10) 100 g2009-11-010000-00-00NoNoCurrent
11086-030-401108600304040 g in 1 TUBE (11086-030-40) 40 g2009-11-010000-00-00NoNoCurrent
11086-030-601108600306060 g in 1 BOTTLE, WITH APPLICATOR (11086-030-60) 60 g2009-11-010000-00-00NoNoCurrent
11086-030-61110860030611 BOTTLE, WITH APPLICATOR in 1 BOX (11086-030-61) > 60 g in 1 BOTTLE, WITH APPLICATOR (11086-030-60) 2009-11-010000-00-00NoNoCurrent