VAGISIL Anti-Itch Medicated Wipes Maximum Strength
- Product NDC
- 11509-5035
- 11-digit product format
- 115095035
- Labeler code
- 11509
- Product ID
- 11509-5035_d52bff6a-9386-4ff7-a2ff-bef4a6ad07f8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- pramoxine hydrochloride
- Dosage form
- CLOTH
- Route
- TOPICAL
- Labeler
- Combe Incorporated
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2005-06-28
- Substance
- PRAMOXINE HYDROCHLORIDE
- Active strength
- 10 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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
- VAGISIL Anti-Itch Medicated Wipes Maximum Strength
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PRAMOXINE HYDROCHLORIDE | 10 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 88AYB867L5 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b848f53d-8aea-4efe-aa2c-009d5121fc33 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8 | Product name | 1 | 20140508 |
| a7051cba-790b-a699-81f8-dbbbdbd9b5ac | Product name | 1 | 20140508 |
| da108d9e-edc8-17a3-8c28-3251c6a8accc | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 11509-5035-1 | 2020-04-21 | C162847 | 48780-1 | 9d75b9d0-c0eb-f424-e053-dadaa90a57ce | Vagisil Medicated Anti-Itch Wipes Maximum Strength |
| 11509-5035-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c0eb-f424-e053-dadaa90a57ce | Vagisil Medicated Anti-Itch Wipes Maximum Strength |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11509-5035-1 | VAGISIL Anti-Itch Medicated Wipes Maximum Strength | 4.5 g in 1 PACKET | CLOTH | 4.5 | 9 | |
| 11509-5035-1 | VAGISIL Anti-Itch Medicated Wipes Maximum Strength | 12 in 1 CARTON | CLOTH | 12 | 9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 11509-5035-1 | EA - Each | 11509-5035 | e1c44b32-37dc-49d1-b8c1-d95fe3bdc5e4 | 1 | 2022-06-06 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 11509-5035 | VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED] | 9 | Current NDC, Legacy NDC, 2 package rows | 20241211_b848f53d-8aea-4efe-aa2c-009d5121fc33.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| itch relief | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | H E B | 34c7bcd3-203f-4630-894d-3739a1576c8d | 2024-10-13 | Warnings | M017 |
| hydrocortisone | HYDROCORTISONE | H E B | 25ec9014-64c4-44df-9e67-9f9223ffc923 | 2024-10-12 | Warnings | M017 |
| PAIN RELIEF Gel-Roll On | LIDOCAINE AND MENTHOL | Shanghai Chuangshi Medical Technology (Group) Co., Ltd. | f02fa9c0-b8af-f362-e053-2a95a90ae516 | 2024-10-11 | Warnings | M017 |
| Insect Sting Relief Pad | BENZOCAINE, ALCOHOL | Hubei Changjian Medical Products Co., Ltd. | 6a269982-0e25-4c09-aef1-0b398bdc5ed4 | 2024-10-11 | Warnings | M017 |
| HYDROCORTISONE | HYDROCORTISONE | VIVE HEALTH LLC | 24221805-e5c9-5785-e063-6394a90a9d2f | 2024-10-10 | Warnings | M017 |
| De La Cruz Camphor | CAMPHOR | DLC Laboratories, Inc. | 62359237-de2d-4497-bfd6-36991cfc8acf | 2024-10-10 | Warnings | M017 |
| Anti Itch | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | Meijer Distribution Inc | 4f536a86-6419-4ab0-a7e8-5c37943823e2 | 2024-10-09 | Warnings | M017 |
| terrasil Bruise and Pain Relief Maximum Strength | CAMPHOR, MENTHOL | Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions | 240b231d-a8b2-c64c-e063-6394a90a7440 | 2024-10-09 | Warnings | M017 |
| Muscle Freeze Relief | MENTHOL | NATURAL ESSENTIALS, INC. | 815c534b-096d-49f2-b5f2-8c885d45a5e6 | 2024-10-09 | Warnings | M017 |
| HYDROCORTISONE | HYDROCORTISONE | VIVE HEALTH LLC | 2410dc2f-9332-19fa-e063-6394a90a2835 | 2024-10-09 | Warnings | M017 |
| CVS Health Lidocaine Pain-Relieving | LIDOCAINE | Natural Essentials, Inc. | fc23b2e2-4abc-4119-b8bd-305b4327f1dd | 2024-10-09 | Warnings | M017 |
| KERACARE | MENTHOL 1% | Avlon Industries, Inc. | f72eec6d-1204-4e03-8aed-d5bcf8d3bbce | 2024-10-09 | Warnings | M017 |
| Eagle Medicated | MENTHOL METHYL SALICYLATE | Eagle Indo Pharma, PT | da338796-de9c-be51-e053-2a95a90a2509 | 2024-10-07 | Warnings | M017 |
| Eagle Medicated | MENTHOL METHYL SALICYLATE | Eagle Indo Pharma | e2c5f821-cdd5-190d-e053-2a95a90a9159 | 2024-10-07 | Warnings | M017 |
| NanoXtreme Pain Relieving | MENTHOL, METHYL SALICYLATE | MG Science Technologies LLC | c1490c30-a9db-4120-adaf-9e8000169e46 | 2024-10-07 | Warnings | M017 |
| CAREALL Hydrocortisone Maximum Strength | HYDROCORTISONE | New World Imports, Inc | ea656cf8-cad5-4fa5-82e7-daec77a0bb04 | 2024-10-07 | Warnings | M017 |
| Eagle Medicated Oil Refreshing | MENTHOL, METHYL SALICYLATE | Eagle Indo Pharma, PT | e2729023-d689-7ae2-e053-2a95a90a78dc | 2024-10-06 | Warnings | M017 |
| Flanax Back Pain Relief | LIDOCAINE | Belmora LLC | 46d33346-e582-4af1-b81a-feca7033dceb | 2024-10-04 | Warnings | M017 |
| Muscle Balm | MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC) | Natural Essentials, Inc. | 16918ba3-2e07-4232-9ed3-4c7751796cd2 | 2024-10-04 | Warnings | M017 |
| Fast Freeze Pain Relieving Continuous | MENTHOL, UNSPECIFIED FORM | Natural Essentials, Inc. | 998a4824-9ed9-4fe0-b45b-72e52861fcd3 | 2024-10-04 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1039541 | pramoxine HCl 1 % Medicated Pad | PSN | b848f53d-8aea-4efe-aa2c-009d5121fc33 | 9 |
| 1039550 | Vagisil 1 % Medicated Pad | PSN | b848f53d-8aea-4efe-aa2c-009d5121fc33 | 9 |
| 1039550 | pramoxine hydrochloride 10 MG/ML Medicated Pad [Vagisil Wipes] | SBD | b848f53d-8aea-4efe-aa2c-009d5121fc33 | 9 |
| 1039541 | pramoxine hydrochloride 10 MG/ML Medicated Pad | SCD | b848f53d-8aea-4efe-aa2c-009d5121fc33 | 9 |
| 1039541 | pramoxine hydrochloride 1 % Medicated Pad | SY | b848f53d-8aea-4efe-aa2c-009d5121fc33 | 9 |
| 1039541 | pramoxine hydrochloride 1 % Medicated Wipe | SY | b848f53d-8aea-4efe-aa2c-009d5121fc33 | 9 |
| 1039550 | Vagisil 1 % Medicated Wipes | SY | b848f53d-8aea-4efe-aa2c-009d5121fc33 | 9 |
| 1039550 | Vagisil Wipes 10 MG/ML Medicated Pad | SY | b848f53d-8aea-4efe-aa2c-009d5121fc33 | 9 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 11509-5035-1 | 11509503501 | 12 PACKET in 1 CARTON (11509-5035-1) / 4.5 g in 1 PACKET | 12 packet | 2005-06-28 | 0000-00-00 | No | No | Current |