Keralyt
- Product NDC
- 11086-043
- Requested package NDC
- 11086-043-06
- 11-digit product format
- 110860043
- Labeler code
- 11086
- Product ID
- 11086-043_f214aff3-7a3a-ce40-e053-2995a90a8abb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- salicylic acid
- Dosage form
- SHAMPOO
- Route
- TOPICAL
- Labeler
- Summers Laboratories Inc
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2009-11-01
- Marketing end
- 0000-00-00
- Substance
- SALICYLIC ACID
- Active strength
- 6 g/92.6mL
- NDC exclude flag
- No
- Listing certified through
- 2024-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 11086-043 | 11086-043-06 | I | Inactivated by FDA | 2026-10-12 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 11086-043-06 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-88d3-d83d-e063-dadaa90ab31f | SUMMERS LABS (as PLD) - Keralyt Shampoo (11086-043) |
| 11086-043-06 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-88d3-d83d-e063-dadaa90ab31f | Keralyt 6 Shampoo (11086-043) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11086-043-06 | Keralyt | 160 mL in 1 BOTTLE, WITH APPLICATOR | SHAMPOO | 1 mL | 6 g in 92.6mL | 16 |
| 11086-043-06 | Keralyt | 160 mL in 1 BOTTLE, WITH APPLICATOR | SHAMPOO | 160 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 11086-043-06 | ML - Milliliter | 11086-043 | 4515a83d-c4bf-48ae-8fac-488bda43f855 | 1 | 2021-01-08 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| SALICYLIC ACID | ACTIVE INGREDIENT | O414PZ4LPZ | KERALYT (SALICYLIC ACID) KIT [SUMMERS LABORATORIES INC] | 10 | |
| SALICYLIC ACID | ACTIVE MOIETY | O414PZ4LPZ | KERALYT (SALICYLIC ACID) KIT [SUMMERS LABORATORIES INC] | 10 | |
| SALICYLIC ACID | ACTIVE INGREDIENT | O414PZ4LPZ | KERALYT (SALICYLIC ACID) SHAMPOO [SUMMERS LABORATORIES INC] | 1 | |
| SALICYLIC ACID | ACTIVE MOIETY | O414PZ4LPZ | KERALYT (SALICYLIC ACID) SHAMPOO [SUMMERS LABORATORIES INC] | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 11086-043 | KERALYT (SALICYLIC ACID) KIT [SUMMERS LABORATORIES INC] | 16 | Legacy NDC | 20231010_79bff5e0-bccb-11de-b462-0002a5d5c51b.zip |
| 11086-043 | KERALYT (SALICYLIC ACID) SHAMPOO [SUMMERS LABORATORIES INC] | 6 | Legacy NDC, 1 package rows | 20231010_55632908-8757-11de-8a39-0800200c9a66.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 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] | BPCK | 79bff5e0-bccb-11de-b462-0002a5d5c51b | 16 |
| 866892 | {1 (60000 MG) (salicylic acid 0.06 MG/MG Topical Gel) / 1 (160 ML) (salicylic acid 60 MG/ML Medicated Shampoo) } Pack | GPCK | 79bff5e0-bccb-11de-b462-0002a5d5c51b | 16 |
| 999618 | Keralyt 6 % Medicated Shampoo | PSN | 79bff5e0-bccb-11de-b462-0002a5d5c51b | 16 |
| 883501 | Keralyt 6 % Scalp Complete Kit | PSN | 79bff5e0-bccb-11de-b462-0002a5d5c51b | 16 |
| 212332 | Keralyt 6 % Topical Gel | PSN | 79bff5e0-bccb-11de-b462-0002a5d5c51b | 16 |
| 667904 | salicylic acid 6 % Medicated Shampoo | PSN | 79bff5e0-bccb-11de-b462-0002a5d5c51b | 16 |
| 866892 | salicylic acid 6 % Medicated Shampoo (160 ML) / salicylic acid 6 % Topical Gel (60000 MG) Pack | PSN | 79bff5e0-bccb-11de-b462-0002a5d5c51b | 16 |
| 312893 | salicylic acid 6 % Topical Gel | PSN | 79bff5e0-bccb-11de-b462-0002a5d5c51b | 16 |
| 212332 | salicylic acid 0.06 MG/MG Topical Gel [Keralyt] | SBD | 79bff5e0-bccb-11de-b462-0002a5d5c51b | 16 |
| 999618 | salicylic acid 60 MG/ML Medicated Shampoo [Keralyt] | SBD | 79bff5e0-bccb-11de-b462-0002a5d5c51b | 16 |
| 312893 | salicylic acid 0.06 MG/MG Topical Gel | SCD | 79bff5e0-bccb-11de-b462-0002a5d5c51b | 16 |
| 667904 | salicylic acid 60 MG/ML Medicated Shampoo | SCD | 79bff5e0-bccb-11de-b462-0002a5d5c51b | 16 |
| 866892 | {1 (160 ML Salicylic Acid 6 % Medicated Shampoo) / 1 (60000 MG Salicylic Acid 6 % Topical Gel) } Pack | SY | 79bff5e0-bccb-11de-b462-0002a5d5c51b | 16 |
| 212332 | Keralyt 0.06 MG/MG Topical Gel | SY | 79bff5e0-bccb-11de-b462-0002a5d5c51b | 16 |
| 999618 | Keralyt 6 % Medicated Shampoo | SY | 79bff5e0-bccb-11de-b462-0002a5d5c51b | 16 |
| 883501 | Keralyt 6 % Scalp Complete Kit | SY | 79bff5e0-bccb-11de-b462-0002a5d5c51b | 16 |
| 212332 | Keralyt 6 % Topical Gel | SY | 79bff5e0-bccb-11de-b462-0002a5d5c51b | 16 |
| 999618 | Keralyt 60 MG/ML Medicated Shampoo | SY | 79bff5e0-bccb-11de-b462-0002a5d5c51b | 16 |
| 667904 | salicylic acid 6 % Medicated Shampoo | SY | 79bff5e0-bccb-11de-b462-0002a5d5c51b | 16 |
| 312893 | salicylic acid 6 % Topical Gel | SY | 79bff5e0-bccb-11de-b462-0002a5d5c51b | 16 |
| 999618 | Keralyt 6 % Medicated Shampoo | PSN | 55632908-8757-11de-8a39-0800200c9a66 | 6 |
| 667904 | salicylic acid 6 % Medicated Shampoo | PSN | 55632908-8757-11de-8a39-0800200c9a66 | 6 |
| 999618 | salicylic acid 60 MG/ML Medicated Shampoo [Keralyt] | SBD | 55632908-8757-11de-8a39-0800200c9a66 | 6 |
| 667904 | salicylic acid 60 MG/ML Medicated Shampoo | SCD | 55632908-8757-11de-8a39-0800200c9a66 | 6 |
| 999618 | Keralyt 6 % Medicated Shampoo | SY | 55632908-8757-11de-8a39-0800200c9a66 | 6 |
| 999618 | Keralyt 60 MG/ML Medicated Shampoo | SY | 55632908-8757-11de-8a39-0800200c9a66 | 6 |
| 667904 | salicylic acid 6 % Medicated Shampoo | SY | 55632908-8757-11de-8a39-0800200c9a66 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 11086-043-06 | 11086004306 | 160 mL in 1 BOTTLE, WITH APPLICATOR (11086-043-06) | 160 ml | 2009-11-01 | 0000-00-00 | No | No | Current |