Itch Relief
- Product NDC
- 61010-8300
- 11-digit product format
- 610108300
- Labeler code
- 61010
- Product ID
- 61010-8300_109674e0-ef83-5844-e063-6394a90ae6b8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- diphenhydramine hydrochloride
- Dosage form
- LIQUID
- Route
- TOPICAL
- Labeler
- Safetec of America, Inc.
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2013-05-02
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 20.3 g/L
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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
- Itch Relief
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 20.3 g/L |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| TC2D6JAD40 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1050080 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4f4c801b-d894-4fa3-b024-6ca41a5f2a95 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61010-8300-1 | 2024-02-13 | C162847 | 48780-1 | 1030e365-2119-111a-e063-dadaa90a10e2 | 61010-8300, Itch Relief Spray |
| 61010-8300-1 | 2024-01-30 | C162847 | 48780-1 | 1030e365-2119-111a-e063-dadaa90a10e2 | 61010-8300, Itch Relief Spray |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61010-8300-1 | Itch Relief | 0.0591 L in 1 BOTTLE, SPRAY | LIQUID | 0.0591 | 3 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61010-8300 | ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SAFETEC OF AMERICA, INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240214_4f4c801b-d894-4fa3-b024-6ca41a5f2a95.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 |
|---|---|---|---|---|---|---|
| Calypxo Pain Relief | METHYL SALICYLATE, MENTHOL | Advanced Rx of Tennessee, LLC | 0b7736df-c7e0-7d00-e063-6294a90aa57e | 2024-12-31 | Warnings | M017 |
| New Terocin | METHYL SALICYLATE, CAPSAICIN, AND MENTHOL | Advanced Rx Pharmacy of Tennessee, LLC | f4bfc4a6-06ef-1f76-e053-2995a90a2b8f | 2024-12-31 | Warnings | M017 |
| Lidocaine | LIDOCAINE | Advanced Rx Pharmacy of Tennessee, LLC | 01cb19a4-ce22-144d-e063-6294a90a8aa3 | 2024-12-31 | Warnings | M017 |
| Satohap Lidocaine 4% Menthol 1% Pain Relieving Cream | LIDOCAINE, MENTHOL | Sato Pharmaceutical Co., Ltd. | 2251e96b-d050-4ec2-a6b9-6659610885bf | 2024-12-30 | Warnings | M017 |
| hydrocortisone | HYDROCORTISONE | Safeway | af2e2ef3-0f3f-4592-8081-b6553ade2f5a | 2024-12-26 | Warnings | M017 |
| Comforte Menstrual Cramp Relief Cream | MENTHOL | PMS4PMS LLC | c121537e-3333-4f35-8c77-20086158dff4 | 2024-12-26 | Warnings | M017 |
| N-Labs Arcticzen Pain Relief Knee | CAMPHOR (SYNTHETIC), MENTHOL | NUTRIOMO LABS PTE. LTD | 05ee574a-854c-4a77-be77-082055075c4d | 2024-12-26 | Warnings | M017 |
| BiteMD External Analgesic First Aid Antiseptic | BENZOCAINE, CAMPHOR (SYNTHETIC), AND PHENOL | United Industries Corporation | 4c60db03-6d2b-4ae0-a200-718b3a50eb0f | 2024-12-23 | Warnings | M017 |
| GNP Anti Itch | CAMPHOR, MENTHOL | AMERISOURCEBERGEN DRUG CORPORATION | b4f2d6f7-2287-47d8-e053-2995a90ae335 | 2024-12-23 | Warnings | M017 |
| cool and heat pain relieving liquid | MENTHOL | Bionpharma Inc. | ec6f59d8-45c5-46a0-e053-2995a90a239f | 2024-12-23 | Warnings | M017 |
| FOOT WORKS MAXIMUM CRACKED HEEL | BENZALKONIUM CHLORIDE, LIDOCAINE | COSMAX USA, CORPORATION | 29f92230-d1d4-5e94-e063-6294a90af812 | 2024-12-23 | Warnings | M017 |
| pain relief roll-on | LIDOCAINE 4% | Bionpharma Inc. | f607b6dc-8d13-604a-e053-2995a90a59ab | 2024-12-23 | Warnings | M017 |
| Veneno de Abeja Aceite De Vibora Brand | METHYL SALICYLATE | Miramar Cosmetics, Inc DBA Miramar Lab | a6c4889c-e7a9-44b9-bd9a-70fd6e8c4825 | 2024-12-23 | Warnings | M017 |
| Itch Relief | HYDROCORTISONE 1% | Trifecta Pharmaceuticals USA LLC | af5daf6c-bcad-8ebf-e053-2a95a90af1b0 | 2024-12-20 | Warnings | M017 |
| Pain Itch Relief | LIDOCAINE HCI | Trifecta Pharmaceutical USA LLC | f40b19a8-795c-f514-e053-2a95a90a6d15 | 2024-12-20 | Warnings | M017 |
| Muscle Rub Cream | MENTHOL 10%, METHYL SALICYLATE 15% | Trifecta Pharmaceuticals USA, LLC. | 44d3638d-f29b-0e01-e054-00144ff88e88 | 2024-12-20 | Warnings | M017 |
| Rhuli Gel | CAMPHOR, MENTHOL | Trifecta Pharmaceuticals USA, LLC. | 4fbb3c23-ed47-336e-e054-00144ff8d46c | 2024-12-20 | Warnings | M017 |
| Hydrocortisone Cream with Aloe | HYDROCORTISONE | Rugby Laboratories | 132982ea-cce6-687c-e063-6294a90a4632 | 2024-12-20 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE 1% | Pharmacy Value Alliance LLC | 9bb98452-a605-5c20-e053-2995a90a1ea7 | 2024-12-20 | Warnings | M017 |
| DCH Cooling Pain Relief | MENTHOL 10.5% | Derma Care Research Labs, LLC | 00dcdae0-c744-8402-e063-6294a90a12f8 | 2024-12-20 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1050080 | diphenhydrAMINE HCl 2 % Topical Spray | PSN | 4f4c801b-d894-4fa3-b024-6ca41a5f2a95 | 3 |
| 1050080 | diphenhydramine hydrochloride 20 MG/ML Topical Spray | SCD | 4f4c801b-d894-4fa3-b024-6ca41a5f2a95 | 3 |
| 1050080 | diphenhydramine HCl 2 % Topical Spray | SY | 4f4c801b-d894-4fa3-b024-6ca41a5f2a95 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 61010-8300-1 | 61010830001 | .0591 L in 1 BOTTLE, SPRAY (61010-8300-1) | 2013-05-02 | 0000-00-00 | No | No | Current |