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 |
|---|---|---|---|---|---|---|
| Good Neighbor Pharmacy Hydrocortisone with Aloe | HYDROCORTISONE | AmerisourceBergen | 0c544792-63d9-400c-9888-207c44fdc75e | 2025-07-08 | Warnings | M017 |
| Good Neighbor Pharmacy Hydrocortisone | HYDROCORTISONE | AmerisourceBergen | 58b0b7ba-e547-4e0f-b04d-8e1e6a5d4fcf | 2025-07-08 | Warnings | M017 |
| Publix Hydro | HYDROCORTISONE | Publix Super Markets Inc | 29296b0f-0eed-4bb9-8727-c25c2bcf9fd6 | 2025-07-08 | Warnings | M017 |
| Publix hydro plus | HYDROCORTISONE | Publix Super Markets Inc | a00d82c1-6b09-424a-be78-2603eee3fb9d | 2025-07-08 | Warnings | M017 |
| Tattoo | TATTOO CREAM | Perfso (HK) Co., Limited | 39773cab-12df-4520-e063-6294a90abc5b | 2025-07-08 | Warnings | M017 |
| Neutrogena Sun Rescue After Sun Medicated Relief | CAMPHOR (SYNTHETIC) | Kenvue Brands LLC | c95c5b64-b90f-1143-e053-2a95a90aa03c | 2025-07-07 | Warnings | M017 |
| sunmark Hydrocortisone | HYDROCORTISONE | Strategic Sourcing Services LLC | 210079e9-3d2f-4489-b468-b96b145034ed | 2025-07-07 | Warnings | M017 |
| Relief Gel | LIDOCAINE HCL | Good Clean Love, Inc. | e5fa2265-ccb7-750c-e053-2995a90aa51e | 2025-07-07 | Warnings | M017 |
| Hydrocortisone Plus 12 Moisturizers | HYDROCORTISONE | Sun Pharmaceutical Industries, Inc. | 09ac2749-a60f-4039-8c80-a0d2eaf50c34 | 2025-07-07 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE | Sun Pharmaceutical Industries, Inc. | 2ada9ec2-1c28-4da2-8639-07b3193ffb32 | 2025-07-03 | Warnings | M017 |
| Hydrocortisone with Aloe | HYDROCORTISONE | Sun Pharmaceutical Industries, Inc. | caa2fd64-e262-4d7c-ad8a-69f506feba8c | 2025-07-03 | Warnings | M017 |
| Stopain Extra Strength | MENTHOL | Troy Manufacturing, Inc. | 07e9a235-6d10-4407-8729-beaf936e97ad | 2025-07-03 | Warnings | M017 |
| Blue Ice Topical Analgesic Gel | ICE GEL | International Wholesale | 397cd306-078d-5b7d-e063-6294a90a8bbc | 2025-07-03 | Warnings | M017 |
| LIDOCAINE | LIDOCAINE, MENTHOL | Vive Health LLC | 236ccc6d-21b7-6153-e063-6394a90a4634 | 2025-07-02 | Warnings | M017 |
| AsperFlex MAX | LIDOCAINE 4% WITH MENTHOL 1% | Akron Pharma Inc. | ccf6172b-350a-4b78-b844-f84bf17c491f | 2025-07-02 | Warnings | M017 |
| METHYL SALICYLATE 25% | METHYL SALICYLATE | Oncora Pharma, LLC | 3766e3a9-94a8-4c3e-e063-6394a90aa24a | 2025-07-01 | Warnings | M017 |
| Diphenhydramine Hydrochloride and Zinc Acetate | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Sun Pharmaceutical Industries, Inc. | c89e3de8-7d71-485c-8fc5-2832d6024f16 | 2025-07-01 | Warnings | M017 |
| Westlake Outdoor Pain and Itch Relieving | LIDOCAINE 4% PAIN AND ITCH RELIEVING | WESTLAKE HB PHARMA | 3c563b28-4f4f-9d0c-e063-6294a90adf73 | 2025-07-01 | Warnings | M017 |
| Cortizone 10 Water Resistant | HYDROCORTISONE | Chattem, Inc. | 118e55e7-241f-44c4-959e-09bf6221bd77 | 2025-07-01 | Warnings | M017 |
| Quit Smoking Nicotine Patches | NICOTINE TRANSDERMAL PATCHES | Shenzhen Paxi Trading Co., Ltd. | 38c1616e-3b09-0669-e063-6294a90a2c86 | 2025-06-29 | 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 |