CeraVe Developed with Dermatologists Itch Relief Moisturizing
- Product NDC
- 49967-512
- 11-digit product format
- 499670512
- Labeler code
- 49967
- Product ID
- 49967-512_61f5c62e-a06b-4e06-868a-db8df7fcb16b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- pramoxine hydrochloride
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- L'Oreal USA Products Inc
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2017-09-18
- 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
- CeraVe Developed with Dermatologists Itch Relief Moisturizing
- 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#
| Identifier | FDA.report destination |
|---|---|
| 1052684 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| c6a0880e-fc16-46e9-8314-c56c9d15bf31 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 4b7700e3-6e0e-45e5-9d22-6f754d61386e | Product name | 2 | 20250304 |
| 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 |
|---|---|---|---|---|---|---|
| 49967-512-01 | CeraVe Developed with Dermatologists Itch Relief Moisturizing | 340 g in 1 JAR | CREAM | 340 | 5 | |
| 49967-512-02 | CeraVe Developed with Dermatologists Itch Relief Moisturizing | 453.6 g in 1 JAR | CREAM | 453.6 | 5 | |
| 49967-512-03 | CeraVe Developed with Dermatologists Itch Relief Moisturizing | 538.6 g in 1 JAR | CREAM | 538.6 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49967-512 | CERAVE DEVELOPED WITH DERMATOLOGISTS ITCH RELIEF MOISTURIZING (PRAMOXINE HYDROCHLORIDE) CREAM [L'OREAL USA PRODUCTS INC] | 5 | Current NDC, Legacy NDC, 3 package rows | 20240101_c6a0880e-fc16-46e9-8314-c56c9d15bf31.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 |
|---|---|---|---|---|---|---|
| Fruit of the Earth Aloe Vera Cool Blue | LIDOCAINE HYDROCHLORIDE | Fruit of the Earth, Inc. | 1d65bc34-2bc2-4f52-a9b3-1cb08324eb79 | 2024-07-19 | Warnings | M017 |
| Ultra Balm | MENTHOL AND METHYL SALICYLATE | Ling Nam Medicine Factory (H.K.) Ltd. | de997baf-aa04-474e-b912-3fc67e720d0b | 2024-07-19 | Warnings | M017 |
| Ling Nam Hak Kwai Oil | TURPENTINE OIL | Ling Nam Medicine Factory (H.K.) Ltd. | 3f16cce3-366f-41f3-8829-6de4082a8c19 | 2024-07-19 | Warnings | M017 |
| Koong Yick Hak Kwai Oil | TURPENTINE OIL | Ling Nam Medicine Factory (H.K.) Ltd. | bc33e185-3b42-98b5-e053-2995a90a6308 | 2024-07-18 | Warnings | M017 |
| Koong Yick Hung Fa | METHYL SALICYLATE | Ling Nam Medicine Factory (H.K.) Ltd. | 9c8a121d-6da2-4435-a2d7-a0b71d10740d | 2024-07-18 | Warnings | M017 |
| Ling Nam Hung Far | METHYL SALICYLATE | Ling Nam Medicine Factory (H.K.) Ltd. | b6916b6e-b7eb-1eb7-e053-2995a90ae6fb | 2024-07-18 | Warnings | M017 |
| itch relief | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Bionpharma Inc. | 178ed513-4f22-8f11-e063-6294a90a109b | 2024-07-16 | Warnings | M017 |
| POWERECT Benzocaine Male Delay Gel | BENZOCAINE | SKINS SEXUAL HEALTH LIMITED | 2fafe1f2-a31e-4b2a-bc51-81e16b319c3a | 2024-07-16 | Warnings | M017 |
| SKINS DELAY Climax Control Benzocaine Gel | BENZOCAINE | SKINS SEXUAL HEALTH LIMITED | 53730576-2609-4f28-8bfa-a1ceea698b83 | 2024-07-16 | Warnings | M017 |
| TIDL PAIN RELIEF CRYO THERAPY Unscented formula Spray. | PAIN RELIEF CRYO THERAPY UNSCENTED FORMULA SPRAY | Shenzhen Sam Technology Co., Ltd. | 1d1a0346-3b00-4803-e063-6294a90aec6d | 2024-07-13 | Warnings | M017 |
| Tidl Pain Relief Evening Therapy Spray. | PAIN RELIEF EVENING THERAPY SPRAY | Shenzhen Sam Technology Co., Ltd. | 1d1a2f4a-7b25-e595-e063-6394a90a00d5 | 2024-07-13 | Warnings | M017 |
| TIDL PAIN RELIEF HEAT THERAPY ROLL-ON | PAIN RELIEF HEAT THERAPY ROLL-ON | Shenzhen Sam Technology Co., Ltd. | 1d0b7b8f-9e5d-00f7-e063-6394a90af87c | 2024-07-12 | Warnings | M017 |
| TIDL PAIN RELIEF CRYO THERAPY original formula Spray. | PAIN RELIEF CRYO THERAPY ORIGINAL FORMULA SPRAY | Shenzhen Sam Technology Co., Ltd. | 1d0b94ec-f956-dff2-e063-6294a90aca4a | 2024-07-12 | Warnings | M017 |
| TIDL PAIN RELIEF CRYO THERAPY MAX Strength Spray. | PAIN RELIEF CRYO THERAPY MAX STRENGTH SPRAY | Shenzhen Sam Technology Co., Ltd. | 1d0bf4f9-6b02-6cec-e063-6294a90a36c7 | 2024-07-12 | Warnings | M017 |
| Burn Relief | LIDOCAINE HCI 2.0% | Trifecta Pharmaceuticals USA, LLC. | e5e524cd-bb22-715f-e053-2995a90ab5d3 | 2024-07-12 | Warnings | M017 |
| Ralli Rapid Pain Relief | MENTHOL | Troy Manufacturing, Inc. | 1d10e3ca-dc93-8e1a-e063-6394a90a47c0 | 2024-07-12 | Warnings | M017 |
| TIDL PAIN RELIEF HEAT THERAPY Spray. | PAIN RELIEF HEAT THERAPY SPRAY | Shenzhen Sam Technology Co., Ltd. | 1d199826-1b27-b6e7-e063-6394a90a69ad | 2024-07-12 | Warnings | M017 |
| Tidl Pain Relief Morning Therapy Spray. | PAIN RELIEF MORNING THERAPY SPRAY | Shenzhen Sam Technology Co., Ltd. | 1d19d070-3818-73de-e063-6394a90a8958 | 2024-07-12 | Warnings | M017 |
| Hydrocortisone with aloe | HYDROCORTISONE WITH ALOE ANTI ITCH | NeilMed Pharmaceuticals Inc. | 032b9f58-5f64-04dd-e063-6294a90a6bb9 | 2024-07-10 | Warnings | M017 |
| Octagon Pain Relief | MENTHOL, UNSPECIFIED FORM | NATURAL ESSENTIALS, INC. | 9926f733-1506-4224-9d70-b1813cd81ec3 | 2024-07-08 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1052684 | pramoxine HCl 1 % Topical Cream | PSN | c6a0880e-fc16-46e9-8314-c56c9d15bf31 | 5 |
| 1052684 | pramoxine hydrochloride 10 MG/ML Topical Cream | SCD | c6a0880e-fc16-46e9-8314-c56c9d15bf31 | 5 |
| 1052684 | pramoxine hydrochloride 1 % Topical Cream | SY | c6a0880e-fc16-46e9-8314-c56c9d15bf31 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 49967-512-01 | 49967051201 | 340 g in 1 JAR (49967-512-01) | 340 g | 2017-09-18 | 0000-00-00 | No | No | Current |
| 49967-512-02 | 49967051202 | 453.6 g in 1 JAR (49967-512-02) | 453.6 g | 2017-09-18 | 0000-00-00 | No | No | Current |
| 49967-512-03 | 49967051203 | 538.6 g in 1 JAR (49967-512-03) | 538.6 g | 2017-09-18 | 0000-00-00 | No | No | Current |