CALMADOL
- Product NDC
- 48201-004
- 11-digit product format
- 482010004
- Labeler code
- 48201
- Product ID
- 48201-004_42406bd7-6d6c-1f54-e063-6394a90a023e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Camphor, Menthol, Methyl Salicylate
- Dosage form
- LINIMENT
- Route
- TOPICAL
- Labeler
- GRANDALL DISTRIBUTING, LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-07-08
- Substance
- CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE
- Active strength
- 6; 1.9; 10 g/100g; g/100g; g/100g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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
- CALMADOL
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CAMPHOR (NATURAL) | 6 g/100g |
| MENTHOL | 1.9 g/100g |
| METHYL SALICYLATE | 10 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| N20HL7Q941 | Internal UNII lookup |
| L7T10EIP3A | Internal UNII lookup |
| LAV5U5022Y | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2688458 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 31b7f84e-8b66-4d31-8e9c-279d0af2fe64 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| dea2eded-d1e7-46bb-9a3d-f8dc20de6277 | Product name | 1 | 20190408 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 48201-004-17 | CALMADOL | 1 in 1 BOX | LINIMENT | 1 | 11 | |
| 48201-004-17 | CALMADOL | 170.1 g in 1 JAR | LINIMENT | 170.1 | 11 |
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 |
|---|---|---|---|---|---|---|
| NeuroMed FA | BENZOCAINE | Sambria Pharmaceuticals, Inc. | 97345ed4-51c3-4221-852c-2cd563f33317 | 2025-11-12 | Warnings | M017 |
| ZHENG GU SHUI | CAMPHOR, MENTHOL | GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD | 17552943-4f11-42d6-ad41-fbc53f2bbd9a | 2025-11-12 | Warnings, Adverse reactions | M017 |
| NeuroMed FA | BENZOCAINE | Sambria Pharmaceuticals, Inc. | 605fc242-ad31-4aa9-bd86-fba4ddf0d305 | 2025-11-12 | Warnings | M017 |
| CAPZIX | CAPSAICIN | Toprail Chp Llc. | a4555840-cf8f-45d8-90bb-3581102b58a7 | 2025-11-12 | Warnings | M017 |
| Hempvana Cold As Ice Pain Relief | MENTHOL | Telebrands Corp | 95e84bb9-ba2e-5009-e053-2995a90a4362 | 2025-11-12 | Warnings | M017 |
| Lidozall | LIDOCAINE HYDROCHLORIDE | V2 Pharma LLC | 1eb2dfb2-3ad1-488b-aed9-17220e34a10c | 2025-11-12 | Warnings | M017 |
| Lidozall Plus | LIDOCAINE HYDROCHLORIDE | V2 Pharma LLC | ba3cbb15-f4ed-443e-af43-a758481acb0b | 2025-11-12 | Warnings | M017 |
| 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 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2688458 | camphor 6 % / menthol 1.9 % / methyl salicylate 10 % Topical Ointment | PSN | 31b7f84e-8b66-4d31-8e9c-279d0af2fe64 | 11 |
| 2688458 | camphor 0.06 MG/MG / menthol 0.019 MG/MG / methyl salicylate 0.1 MG/MG Topical Ointment | SCD | 31b7f84e-8b66-4d31-8e9c-279d0af2fe64 | 11 |
| 2688458 | camphor 6 % / menthol 1.9 % / methyl salicylate 10 % Topical Ointment | SY | 31b7f84e-8b66-4d31-8e9c-279d0af2fe64 | 11 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 48201-004-17 | 48201000417 | 1 JAR in 1 BOX (48201-004-17) / 170.1 g in 1 JAR | 1 jar | 2015-07-08 | 0000-00-00 | No | No | Current |