PEDIADERMICS ECZEMA 2
- Product NDC
- 76348-585
- Requested package NDC
- 76348-585-04
- 11-digit product format
- 763480585
- Labeler code
- 76348
- Product ID
- 76348-585_44fb0779-2a64-f2a5-e063-6294a90a33d1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Hydrocortisone
- Dosage form
- SPRAY
- Route
- TOPICAL
- Labeler
- RENU LABORATORIES, LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-03-18
- Substance
- HYDROCORTISONE
- Active strength
- 1.12 g/112g
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|
| 2025-04-01 02:39 UTC · source 2025-03-31 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
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
- PEDIADERMICS ECZEMA 2
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HYDROCORTISONE | 1.12 g/112g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| WI4X0X7BPJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 317564 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| da840bf6-ed65-bafc-e053-2a95a90a92d5 | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 76348-585-04 | 2025-04-18 | C162847 | 48780-1 | 2cef2736-6249-d83d-e063-dadaa90ab31f | PEDIADERMICS ECZEMA 2 |
| 76348-585-04 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-6249-d83d-e063-dadaa90ab31f | PEDIADERMICS ECZEMA 2 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76348-585-04 | PEDIADERMICS ECZEMA 2 | 112 g in 1 BOTTLE, SPRAY | SPRAY | 112 | 3 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Knee Pain Relief Patch | DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE | Shenzhen Finona Information Technology Co., Ltd | 38755738-1a06-fdb4-e063-6294a90aa6eb | 2025-11-12 | Warnings | M017 |
| Recovery Numb | LIDOCAINE 4% | PURKLENZ FORMULATIONS INC. | e95e38e3-f743-4f5c-abdf-99ba6856e6f7 | 2025-11-12 | Warnings | M017 |
| Rapid Relief | COLD RELIEF PATCH 5% MENTHOL | RAPID AID VIET NAM COMPANY LIMITED | 434c13c2-52ee-000f-e063-6294a90af7e7 | 2025-11-11 | Warnings | M017 |
| Rapid Relief | PAIN RELIEF PATCH CAMPHOR 110MG MENTHOL 33MG CAPSICUM EXTRACT 22MG | RAPID AID VIET NAM COMPANY LIMITED | 434d5f92-05c2-d884-e063-6394a90ad28c | 2025-11-11 | Warnings | M017 |
| Rapid Relief | PAIN RELIEF PATCH LIDOCAINE 4% MENTHOL 1% | RAPID AID VIET NAM COMPANY LIMITED | 434df0be-49ff-aa56-e063-6394a90a3b5a | 2025-11-11 | Warnings | M017 |
| TopCare Pain Relief Maximum Strength | LIDOCAINE HYDROCHLORIDE | TOPCO ASSOCIATES | b0ae3a7c-52d1-4923-bd50-6bb3749006c8 | 2025-11-11 | Warnings | M017 |
| Comfortcaine | LIDOCAINE HCL | QS Key West Aloe, LLC | 831b7c11-e437-4e74-808e-c9c1eb8b82f6 | 2025-11-11 | Warnings | M017 |
| A and E Marathon Delay Serum | DELAY SERUM | Phe Inc | 4355d1d8-44fe-aca1-e063-6294a90a85ff | 2025-11-11 | Warnings | M017 |
| A and E Deep Throat Desensitizing SprayStrawberry | ORAL NUMBING SPRAY STRAWBERRY | Phe Inc | 4355dab1-a293-ded6-e063-6394a90af9b0 | 2025-11-11 | Warnings | M017 |
| A and E Easy Anal Gel | ANAL NUMBING LUBRICANT | Phe Inc | 4355e0f3-65ba-eca6-e063-6394a90ab43c | 2025-11-11 | Warnings | M017 |
| A and E Deep Throat Desensitizing SprayPeppermint | ORAL NUMBING SPRAY MINT | Phe Inc | 4355e0d0-1222-d594-e063-6294a90abb29 | 2025-11-11 | Warnings | M017 |
| DermaNumb Analgesic | LIDOCAINE HCL | A.T.S. Laboratories, LLC | 0ea46890-45c3-4732-bc47-227f7c67daf1 | 2025-11-11 | Warnings | M017 |
| Derma Numb Pain Relief | LIDOCAINE HCL | A.T.S. Laboratories, LLC | 710991ae-8f82-4893-93a7-0ef3f815d132 | 2025-11-11 | Warnings | M017 |
| HYDROCORTISONE | HYDROCORTISONE | Encube Ethicals, Inc. | 969cd576-82d3-4662-bbc1-3587a1f6a564 | 2025-11-10 | Warnings | M017 |
| Jelcaine Sterile | LIDOCAINE HCL JELLY USP, 2% | Brookfield Pharmaceuticals, LLC | 1a39d1de-7aa2-3068-e063-6394a90aed85 | 2025-11-10 | Warnings | M017 |
| Hush Anesthetic | LIDOCAINE | HUSH Anesthetic | c6e86a0f-6f9b-45b7-86ce-0bb1c198061a | 2025-11-10 | Warnings | M017 |
| Hush Anesthetic | LIDOCAINE | HUSH Anesthetic | 97ae1993-7268-4b7f-92e2-6004337d5650 | 2025-11-10 | Warnings | M017 |
| MENTHOL AND METHYL SALICYLATE | ELECTRIC MEDICATED BALM ULTRA STRENGTH | FEI FAH MEDICAL MANUFACTURING PTE LTD | 91e6d3b9-25bb-4015-9d96-bd27f93e5ada | 2025-11-10 | Warnings | M017 |
| E MEI SHAN MEDICATED | CAMPHOR, MENTHOL | Zhejiang Dingtai Pharmaceutical Co., Ltd | bda1e7c1-42df-4126-a512-80f843b07fd0 | 2025-11-10 | Warnings | M017 |
| EXTRA STRENGTH HUA TUO PAIN RELIEVING | CAMPHOR AND MENTHOL | Zhejiang Dingtai Pharmaceutical Co., Ltd | 9850754b-ac94-4ec6-b75a-8096e5ac9456 | 2025-11-10 | Warnings, Adverse reactions | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 317564 | hydrocortisone 1 % Topical Spray | PSN | da840bf6-ed65-bafc-e053-2a95a90a92d5 | 3 |
| 317564 | hydrocortisone 10 MG/ML Topical Spray | SCD | da840bf6-ed65-bafc-e053-2a95a90a92d5 | 3 |
| 317564 | hydrocortisone 1 % Topical Spray | SY | da840bf6-ed65-bafc-e053-2a95a90a92d5 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 76348-585-04 | 76348058504 | 112 g in 1 BOTTLE, SPRAY (76348-585-04) | 112 g | 2022-03-18 | 0000-00-00 | No | No | Current |