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 |
|---|---|---|---|---|---|---|
| Valtrum IMMEDIATE ACTION TOPICAL ANALGESIC | CAMPHOR, MENTHOL, METHYL SALICYLATE | LABORATORIOS QUANTIUM LLC | c4efa317-8dd1-49e1-b7ca-9df2147edd3e | 2023-12-21 | Warnings | M017 |
| DDM Camphor Spirit | CAMPHOR 10% | Discount Drug Mart | 5d56cbe6-4e48-79eb-e053-2a91aa0a74d3 | 2023-12-20 | Warnings | M017 |
| Quality Choice Camphor Spirit | CAMPHOR 10% | Chain Drug Market Association | 8d352a67-2024-43d0-b525-038d398949e6 | 2023-12-20 | Warnings | M017 |
| Instant Antiseptic Pain Relief | CAMPHOR 10.8% AND PHENOL 4.7% | Chain Drug Market Association | 2cd60df3-bfde-4747-ba4f-7121612f2e63 | 2023-12-20 | Warnings | M017 |
| Poison Ivy Wash | PRAMOXINE HCL | Chain Drug Market Association | 873a546b-90ae-50cb-e053-2a91aa0adbfb | 2023-12-20 | Warnings | M017 |
| Premier Value Instant Antiseptic Pain Relief | CAMPHOR 10.8% AND PHENOL 4.7% | Pharmacy Value Alliance LLC | 9d63f8ed-fc50-0d84-e053-2a95a90a6e92 | 2023-12-20 | Warnings | M017 |
| Ear Drops | CARBAMIDE PEROXIDE 6.5% | CVS Pharmacy | 8a872991-01af-5fd0-e053-2995a90ac7f4 | 2023-12-20 | Warnings | M017 |
| CVS Cold and Hot Roll-On | COOL AND HEAT PAIN RELIEF | CVS Pharmacy | b8cc578a-be6d-90c0-e053-2995a90a7742 | 2023-12-20 | Warnings | M017 |
| Sunmark Camphor Spirit | CAMPHOR 10% | Strategic Sourcing Services LLC | 667b3a9f-4a5c-4ef0-adbd-cce9a5f94faa | 2023-12-19 | Warnings | M017 |
| DDM Instant Antiseptic Pain Relief | CAMPHOR 10.8% AND PHENOL 4.7% | Discount Drug Mart | 5d56c74f-604d-4fed-e053-2a91aa0a417c | 2023-12-19 | Warnings | M017 |
| HEB Camphor Phenol | CAMPHOR 10.8% AND PHENOL 4.7% | H E B | 5d573883-001d-e5a4-e053-2991aa0a6203 | 2023-12-18 | Warnings | M017 |
| Petrocort Antipruritic Lip 21 | HYDROCORTISONE | Clinical Formula LLC | 7d408e08-d777-4dfb-bb5e-b4fe5d6f4c7b | 2023-12-15 | Warnings | M017 |
| DermaWound Wound Care Venous Stasis | BENZOCAINE HYDROCHLORIDE | Progressive Doctors, LLC | 6221ba86-8b7f-48c8-8284-6950f9fc36b1 | 2023-12-15 | Warnings | M017 |
| Lidocaine Pain Relief Roll-On | LIDOCAINE 4% | Humco Holding Group, Inc. | a8be9e46-1616-40a9-e053-2a95a90ac3bc | 2023-12-15 | Warnings | M017 |
| Hot/Cold Menthol 16% Roll-On | HOT/COLD MENTHOL 16% ROLL-ON | Humco Holding Group, Inc | a8bf9744-9979-13c1-e053-2a95a90a30aa | 2023-12-15 | Warnings | M017 |
| Freds Medicated anti itch | PRAMOXINE HYDROCHLORIDE, MENTHOL | Discount Drug Mart | 8697b932-da5a-717e-e053-2a91aa0afcae | 2023-12-12 | Warnings | M017 |
| CVS Medicated anti itch | PRAMOXINE HYDROCHLORIDE, MENTHOL | CVS | 86972218-31fe-6942-e053-2991aa0a8850 | 2023-12-12 | Warnings | M017 |
| Best Choice Medicated anti itch | PRAMOXINE HYDROCHLORIDE, MENTHOL | value merchandisers | 869631f8-aa1e-8ea4-e053-2a91aa0a5c57 | 2023-12-12 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE 1% | Weeks & Leo Co., Inc. | 0c5325e3-4796-856c-e063-6394a90a1f90 | 2023-12-12 | Warnings | M017 |
| Westlake Anti-itch | HYDROCORTISONE | Westlake Pharma LLC | 0c53c982-3f23-a2d5-e063-6394a90acd55 | 2023-12-12 | 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 |