Aveeno Restorative Skin Therapy Itch Relief Balm
- Product NDC
- 69968-0637
- 11-digit product format
- 699680637
- Labeler code
- 69968
- Product ID
- 69968-0637_21faa84e-83c4-e381-e063-6294a90ae7e4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- PRAMOXINE HYDROCHLORIDE
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Kenvue Brands LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-08-01
- Substance
- PRAMOXINE HYDROCHLORIDE
- Active strength
- 5 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
- Aveeno Restorative Skin Therapy Itch Relief Balm
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PRAMOXINE HYDROCHLORIDE | 5 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 88AYB867L5 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1150482 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 61824ca7-a2d3-4830-b2bb-149a3222bfc8 | 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69968-0637-4 | Aveeno Restorative Skin Therapy Itch Relief Balm | 113 g in 1 TUBE | CREAM | 113 | 5 | |
| 69968-0637-4 | Aveeno Restorative Skin Therapy Itch Relief Balm | 1 in 1 CARTON | CREAM | 1 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69968-0637 | AVEENO RESTORATIVE SKIN THERAPY ITCH RELIEF BALM (PRAMOXINE HYDROCHLORIDE) CREAM [KENVUE BRANDS LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241107_61824ca7-a2d3-4830-b2bb-149a3222bfc8.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 |
|---|---|---|---|---|---|---|
| ULTRA STRENGTH ZHENG GU SHUI | MENTHOL AND CAMPHOR | GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD | 53397663-044d-4e48-989b-2c6257af5f84 | 2025-07-14 | Warnings, Adverse reactions | M017 |
| TIGER BALM PAIN RELIEVING HYDROGEL | CAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUM | Haw Par Healthcare Ltd. | cb60037f-bceb-4090-a5e4-bdda0cbf9f5c | 2025-07-14 | Warnings | M017 |
| Avedana Hydrocortisone Cream with Aloe | HYDROCORTISONE | Unipack LLC | 2a55c426-39b4-4d94-b6b4-6c548c9685e9 | 2025-07-13 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE ACETATE | Rite Aid Corporation | cb6e0bed-2ea1-49d2-89e7-2554e7565b74 | 2025-07-11 | Warnings | M017 |
| QUALITY CHOICE Maximum Strength Lidocaine Pain Relief Roll On | LIDOCAINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION | 7b3ff4c1-0b60-4f7a-8aa4-c84b7c7137c4 | 2025-07-11 | Warnings | M017 |
| Antibiotic Plus Pain Relief | NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE | TARGET Corporation | 6fba5890-f48f-4302-a8ac-5087a6e03bd5 | 2025-07-11 | Warnings | M017 |
| TopCare Antibiotic Plus Pain Relief | NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE | Topco Associates LLC | 55dc4025-f07f-41b2-8b18-6a11ee04b5cc | 2025-07-11 | Warnings | M017 |
| Benadryl Extra Strength Itch Relief | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Kenvue Brands LLC | 309d9be0-e367-429a-a1fa-ab7855477c8a | 2025-07-10 | Warnings | M017 |
| Bengay Vanishing Scent | MENTHOL, UNSPECIFIED FORM | Kenvue Brands LLC | 6cc3294b-3b0f-44d0-af71-61db1022d269 | 2025-07-10 | Warnings | M017 |
| Cold Hot Medicated Patch 5% Menthol | MENTHOL | Quality Choice | ce544a7c-8dc6-4e63-b499-d8a4e0ec48c3 | 2025-07-10 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE ACETATE | Walgreen Company | bff322f1-59c3-41e0-8685-fcfe52bf4b42 | 2025-07-10 | Warnings | M017 |
| CVS Cortisone | HYDROCORTISONE | CVS Pharmacy | 87631be8-94b8-4718-858d-d2f30e636cce | 2025-07-10 | Warnings | M017 |
| TopCare Hydrocortisone Plus 12 Moisturizers | HYDROCORTISONE | Topco Associates LLC | c40e8e1d-d6d7-4880-99d3-011b97a5e4f3 | 2025-07-10 | Warnings | M017 |
| Live Better Hydrocortisone with Aloe | HYDROCORTISONE | The Great Atlantic & Pacific Tea Company | 044e6ee2-98a6-4802-b33d-78b8551356c4 | 2025-07-10 | Warnings | M017 |
| Rocainol TOPICAL ANALGESIC | METHYL SALICYLATE, MENTHOL | Compania Internacional de Comercio, S.A.P.I de C.V. | 827ec7b2-3d87-47e0-a47a-966b25732c32 | 2025-07-10 | Warnings | M017 |
| NumbR-X | LIDOCAINE HCL | Prodigy Media Inc | 16329ab6-4a33-4c38-85e0-5aad9c75d61d | 2025-07-10 | Warnings | M017 |
| Dr Lido | LIDOCAINE HCL | Prodigy Media Inc | da0938f0-00e7-4502-8721-d64c71f594fc | 2025-07-10 | Warnings | M017 |
| Pain Relief Patch | CAMPHOR, METHYL SALICYLATE, MENTHOL | CDMA, Inc. | da1ec2fe-cc37-4126-90a8-6eb4b8f2e57b | 2025-07-09 | Warnings | M017 |
| ORTHOGEL Menthol 3.5% | MENTHOL | LiquidCapsule Manufacturing LLC | 4fd4b7ac-1971-4abe-8fbb-74ab69e12061 | 2025-07-09 | Warnings | M017 |
| Good Neighbor Pharmacy Hydrocortisone Plus 12 Moisturizers | HYDROCORTISONE | AmerisourceBergen | f36acdb8-a526-4bb7-a557-e1dcbbc1cf45 | 2025-07-08 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1150482 | pramoxine HCl 0.5 % Topical Cream | PSN | 61824ca7-a2d3-4830-b2bb-149a3222bfc8 | 5 |
| 1150482 | pramoxine hydrochloride 5 MG/ML Topical Cream | SCD | 61824ca7-a2d3-4830-b2bb-149a3222bfc8 | 5 |
| 1150482 | pramoxine hydrochloride 0.5 % Topical Cream | SY | 61824ca7-a2d3-4830-b2bb-149a3222bfc8 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69968-0637-4 | 69968063704 | 1 TUBE in 1 CARTON (69968-0637-4) / 113 g in 1 TUBE | 1 tube | 2020-08-01 | 0000-00-00 | No | No | Current |