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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O414PZ4LPZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
212332Internal RxNorm lookup
312893Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8195e4e0-b812-11de-81b4-0002a5d5c51bAvailable on FDA.report

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

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
KeralytSALICYLIC ACIDSummers Laboratories Inc8195e4e0-b812-11de-81b4-0002a5d5c51b2026-05-18Warnings, Adverse reactionsExact identifier
ndc (product): 11086-030

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