Extra Strength Balm
- Product NDC
- 70983-027
- 11-digit product format
- 709830027
- Labeler code
- 70983
- Product ID
- 70983-027_484f4f3a-5682-ca7d-e063-6394a90a982c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Capsicum and Menthol
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Saje Natural Business Inc
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-02-18
- Substance
- MENTHOL; CAPSICUM
- Active strength
- 2258.75; 5000 mg/g; mg/g
- Pharmacologic classes
- Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS]
- 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
- Extra Strength Balm
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL | 2258.75 mg/g |
| CAPSICUM | 5000 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L7T10EIP3A | Internal UNII lookup |
| 00UK7646FG | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f516e416-446b-8f21-e053-2a95a90afd88 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| baf7f49c-75b6-496b-a00e-8e766a8e4f03 | Product name | 1 | 20210127 |
| ebc62596-fc97-4d03-9483-7ba095d25db7 | Product name | 1 | 20151210 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70983-027-01 | Extra Strength Balm | 1 in 1 BOX | OINTMENT | 1 | 4 | |
| 70983-027-01 | Extra Strength Balm | 25 g in 1 JAR | OINTMENT | 25 | 4 |
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 |
|---|---|---|---|---|---|---|
| OKeeffes Working Hands Pain Relief Skin Protectant | ALLANTOIN, LIDOCAINE HYDROCHLORIDE | The Gorilla Glue Company/O'Keeffe's Company | 0685da25-c9fa-e1cd-e063-6394a90ae1b3 | 2025-01-01 | Warnings | M017 |
| Icy Hot with Lidocaine Pain Relieving | LIDOCAINE HCL AND MENTHOL | Chattem, Inc. | 75b28b06-77ea-4fea-b516-2e8a0dac7037 | 2025-01-01 | Warnings | M017 |
| Advanced Seal Barrier plus Pain Relief | LIDOCAINE | Kericure Inc. | 7ac95325-e6e9-4c56-9315-876c00af7c98 | 2025-01-01 | Warnings | M017 |
| FixMySkin Healing Balm Fragrance-Free | HYDROCORTISONE | Lovely Skin, Inc. | c12af4c6-2f05-46ec-b901-1a4fcd750180 | 2024-12-31 | Warnings | M017 |
| Pain Relieving Cream Lidocaine | BENZYL ALCOHOL, LIDOCAINE HCI | Trifecta Pharmaceuticals USA LLC | 039a2036-54b2-cf28-e063-6294a90a8ce6 | 2024-12-31 | Warnings | M017 |
| Cold Therapy Pain Relief Walgreens | MENTHOL 10.5% | WALGREEN COMPANY | f1daa68d-1b12-c28a-e053-2995a90a0949 | 2024-12-31 | Warnings | M017 |
| 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 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70983-027-01 | 70983002701 | 1 JAR in 1 BOX (70983-027-01) / 25 g in 1 JAR | 1 jar | 2023-02-24 | No | No | Current |