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 |
|---|---|---|---|---|---|---|
| BENGAY Tropical Jasmine | LIDOCAINE | Kenvue Brands LLC | c416320a-c0d7-401e-b0fa-44114d76a557 | 2024-11-06 | Warnings | M017 |
| Bengay Ultra Strength Large Size | MENTHOL, UNSPECIFIED FORM | Kenvue Brands LLC | f57ccc33-400b-4401-a348-c54d1eb9f5d0 | 2024-11-06 | Warnings | M017 |
| Band Aid Antiseptic Cleansing To Go | BENZALKONIUM CHLORIDE, PRAMOXINE HCL | Kenvue Brands LLC | d5749cba-32f3-cf9c-e053-2a95a90a4416 | 2024-11-06 | Warnings | M017 |
| Pain Relieving Cream | CAMPHOR AND MENTHOL | GOLDEN TIGER DISTRIBUTION L.L.C. | 26473383-282c-fb10-e063-6394a90a5fa2 | 2024-11-06 | Warnings | M017 |
| Pain Relieving Cream | CAMPHOR AND MENTHOL | GOLDEN TIGER DISTRIBUTION L.L.C. | 1b6f929a-db65-8a02-e063-6394a90a8b59 | 2024-11-06 | Warnings | M017 |
| Meijer Maximum Strength Pain Relieving Analgesic | MENTHOL, UNSPECIFIED FORM | Meijer Distribution, Inc | bd6f04f9-a23b-45f6-bce2-1ef7203198e1 | 2024-11-06 | Warnings | M017 |
| Meijer Cold and Hot Pain Relieving Analgesic | LIDOCAINE HYDROCHLORIDE AND MENTHOL, UNSPECIFIED FORM | Meijer Distribution, Inc | 6d356563-9098-4994-8ad8-819a8033a9f4 | 2024-11-06 | Warnings | M017 |
| TopCare Maximum Strength Pain Relieving Analgesic | MENTHOL, UNSPECIFIED FORM | Topco Associates LLC | dc80d2f9-e3eb-4feb-bad5-7d6ab107f9ab | 2024-11-05 | Warnings | M017 |
| Aveeno Restorative Skin Therapy Itch Relief Balm | PRAMOXINE HYDROCHLORIDE | Kenvue Brands LLC | 61824ca7-a2d3-4830-b2bb-149a3222bfc8 | 2024-11-05 | Warnings | M017 |
| Aveeno Hydrocortisone ANTI-ITCH | HYDROCORTISONE | Kenvue Brands LLC | 233de4d7-e533-40cd-a5ed-e8b09abc626e | 2024-11-05 | Warnings | M017 |
| STING MASTER | LIDOCAINE HYDROCHLORIDE | Les Technologies Ptero, Inc | 94c6fd1f-9e74-420b-9d25-61b37953b838 | 2024-11-05 | Warnings | M017 |
| Alocane Emergency Burn | LIDOCAINE HYDROCHLORIDE | Quest Products, LLC. | 0c8e65a6-dff3-43b4-a3f1-95deb574ea89 | 2024-11-05 | Warnings | M017 |
| Alocane Max | LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE | Quest Products LLC | 0a35ac19-6883-a733-e063-6294a90ad22d | 2024-11-05 | Warnings | M017 |
| Alocane Plus | LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE | Quest Products, Inc. | cfe8114b-df65-064b-e053-2a95a90a33f6 | 2024-11-05 | Warnings | M017 |
| Alocane Botanicals | LIDOCAINE HYDROCHLORIDE | Quest Products, LLC. | 02a8e5c7-56f4-eb0d-e063-6294a90a80cd | 2024-11-05 | Warnings | M017 |
| Alocane Emergency Burn Pads | LIDOCAINE HYDROCHLORIDE | Quest Products, Inc. | fe58bb89-7216-4121-afd3-d1438bdfbfa2 | 2024-11-05 | Warnings | M017 |
| Licefreee AfterLice | PRAMOXINE HCI | Tec Laboratories Inc. | 06c4cc42-a215-3949-e063-6394a90a665e | 2024-11-05 | Warnings | M017 |
| Antibacterial Lidocaine Wound Gel | BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE | ASO LLC | cb9505b7-222d-3a24-e053-2a95a90a0b64 | 2024-11-05 | Warnings | M017 |
| TopCare Pain Relieving Analgesic | LIDOCAINE HYDROCHLORIDE | Topco Associates LLC | 6b4783e0-1987-4838-9e8c-b95426d62b28 | 2024-11-05 | Warnings | M017 |
| Eagle Green Balm | CAMPHOR MENTHOL | Borden Company (Private) Limited | 6f7a796b-a31c-0e60-e053-2a91aa0a022b | 2024-11-04 | 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 |