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 |
|---|---|---|---|---|---|---|
| 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 |
| Good Neighbor Pharmacy Hydrocortisone with Aloe | HYDROCORTISONE | AmerisourceBergen | 0c544792-63d9-400c-9888-207c44fdc75e | 2025-07-08 | Warnings | M017 |
| Good Neighbor Pharmacy Hydrocortisone | HYDROCORTISONE | AmerisourceBergen | 58b0b7ba-e547-4e0f-b04d-8e1e6a5d4fcf | 2025-07-08 | Warnings | M017 |
| Publix Hydro | HYDROCORTISONE | Publix Super Markets Inc | 29296b0f-0eed-4bb9-8727-c25c2bcf9fd6 | 2025-07-08 | Warnings | M017 |
| Publix hydro plus | HYDROCORTISONE | Publix Super Markets Inc | a00d82c1-6b09-424a-be78-2603eee3fb9d | 2025-07-08 | 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 |