Capsaicin
- Product NDC
- 0536-2525
- 11-digit product format
- 005362525
- Labeler code
- 0536
- Product ID
- 0536-2525_a8b02e2a-9971-482b-97f4-82f344bd79db
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Capsaicin
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Rugby Laboratories
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2012-03-01
- Substance
- CAPSAICIN
- Active strength
- .25 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | 0536-2525 | E | Excluded after deficient or non-compliant submission was not corrected | excluded / ndc_excluded.zip | 110d247fa046… | a55b01930146… | ||
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 0536-2525 | 0536-2525-25 | E | Excluded after deficient or non-compliant submission was not corrected | excluded / ndc_excluded.zip | 110d247fa046… | a55b01930146… |
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
- Capsaicin
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CAPSAICIN | .25 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| S07O44R1ZM | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 198555 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| c5915c84-84a2-46f6-9f97-0d9873e9944a | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2022-02-01 | Rugby ® Capsaicin Cream External Analgesic |
| 2022-02-01 | Rugby ® Capsaicin Cream External Analgesic |
| 2022-01-28 | Rugby ® Capsaicin Cream External Analgesic |
| 2022-01-28 | Rugby ® Capsaicin Cream External Analgesic |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0536-2525-25 | Capsaicin | 1 in 1 CARTON | CREAM | 1 | 8 | |
| 0536-2525-25 | Capsaicin | 60 g in 1 TUBE | CREAM | 60 | 8 | |
| 0536-2525-25 | Flexipak | 1 in 1 CARTON | CREAM | 0.025 g in 100g | 1 | |
| 0536-2525-25 | Flexipak | 60 g in 1 TUBE | CREAM | 60 g | 0.025 g in 100g | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0536-2525-25 | GM - Gram | 0536-2525 | 68eb3219-f221-4b69-88f5-6cbd7f09bbc1 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0536-2525 | RUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES] | 6 | Current NDC, Legacy NDC, 2 package rows | 20240214_c5915c84-84a2-46f6-9f97-0d9873e9944a.zip |
| 0536-2525 | FLEXIPAK (DICLOFENAC SODIUM, CAPSAICIN) KIT [STERLING-KNIGHT PHARMACEUTICALS, LLC] | 1 | Current NDC, Legacy NDC | 20180127_7c14a409-88c5-4b9d-80a4-f9f80c64ebbf.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 |
|---|---|---|---|---|---|---|
| FORTHiQ Pain Relief Lidocaine Patch | PAIN RELIEF LIDOCAINE PATCH | Henan Enokon Medical Instrument Co., Ltd. | 2c593420-5788-3422-e063-6394a90a1890 | 2025-01-22 | Warnings | M017 |
| RETALIEF LIDOCAINE 5 | LIDOCAINE | Reliable 1 Laboratories LLC | 2c262f3c-8cb2-4384-e063-6294a90a436d | 2025-01-20 | Warnings | M017 |
| Eagle Brand Medicated Roll On Aromatic | CAMPHOR, MENTHOL, METHYL SALICYLATE | Borden Company (Private) Limited | 1c3e5068-dd61-ebdb-e063-6294a90a97cc | 2025-01-20 | Warnings | M017 |
| PROHEAL BURN | LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE | Nantong Health & Beyond Hygienic Products Inc. | bbc0a5d6-1de6-4ca3-9bb4-a45662b5eab1 | 2025-01-19 | Warnings | M017 |
| HERSTAT PLUS Cold Sore Treatment | CAMPHOR, MENTHOL | Herstat (USA) Inc. | e20ea714-663d-c4ac-e053-2a95a90a5ecc | 2025-01-18 | Warnings | M017 |
| Pain Relief Medicated | CAMPHOR MENTHOL METHYL SALICYTATE | RITE AID CORPORATION | 60895211-69f3-478b-a33f-1c2071f62950 | 2025-01-16 | Warnings | M017 |
| Elgin Pain Relief | MENTHOL | Eco-Logics, Inc. | 70eda21e-e566-42f4-9a49-b0d3ad000652 | 2025-01-16 | Warnings | M017 |
| Curist Lidocaine Patch Maximum Strength | LIDOCAINE | Little Pharma, Inc. | e574c188-cc65-287d-e053-2995a90a5972 | 2025-01-16 | Warnings | M017 |
| Equate Hydrocortisone Topical | HYDROCORTISONE | WalMart | 1f64555d-f77e-4a83-b222-fdb3ed7d8853 | 2025-01-16 | Warnings | M017 |
| Equate Hydrocortisone | HYDROCORTISONE | WalMart | f5c32b4a-1159-4b7a-b8ac-256d53020dc2 | 2025-01-16 | Warnings | M017 |
| Lidocaine Pain Relief Gel-Patch | LIDOCAINE | Guangzhou Zhupuyou E-commerce Co., Ltd | 296fcc36-563f-19ca-e063-6394a90ab3ae | 2025-01-15 | Warnings | M017 |
| K19 RELIEF | MENTHOL | K19 LLC | e2e1ca96-1ae8-4c99-b8de-ce26754292f9 | 2025-01-15 | Warnings | M017 |
| Anecream | LIDOCAINE 4% | Focus Health Group | 2d7706e2-7363-4047-96cb-85b718277e8c | 2025-01-15 | Warnings | M017 |
| Boroleum | CAMPHOR, MENTHOL, WHITE PETROLATUM | Reliable 1 Laboratories | 846568af-0fdd-a80e-e053-2a91aa0a9c9e | 2025-01-15 | Warnings | M017 |
| LidoPro Pain Relief | CAPSAICIN AND LIDOCAINE | Advanced Rx of Tennessee, LLC | 27d5997b-1cc2-41c2-e063-6394a90ac74a | 2025-01-15 | Warnings | M017 |
| Pain Relief Patch 4% Lidocaine | LIDOCAINE | Reliable 1 Laboratories LLC | 2b624763-c310-63d9-e063-6394a90a1928 | 2025-01-15 | Warnings | M017 |
| Cannarelief 1000mg | MENTHOL | Carolina Cannabis Creations LLC | 01e2ae1a-c969-6dd2-e063-6394a90a9d9e | 2025-01-15 | Warnings | M017 |
| Healing Hand Cream 2000mg | MENTHOL | Carolina Cannabis Creations LLC | 01f8795b-9f95-c793-e063-6394a90a8330 | 2025-01-15 | Warnings | M017 |
| CBD Clinic Deep-Rub Pain Relief - Level 5 | CAMPHOR, MENTHOL | ABACUS HEALTH PRODUCTS, INC. | 31e2e5cd-d33e-f058-e063-6394a90af7d2 | 2025-01-14 | Warnings | M017 |
| Meijer Odor Free Analgesic Pain Relieving Topical Analgesic | LIDOCAINE HYDROCHLORIDE | Meijer Distribution, Inc | 6288efea-f636-4eea-bb9f-78aa2f9af54a | 2025-01-14 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198555 | capsaicin 0.025 % Topical Cream | PSN | c5915c84-84a2-46f6-9f97-0d9873e9944a | 8 |
| 198555 | capsaicin 0.25 MG/ML Topical Cream | SCD | c5915c84-84a2-46f6-9f97-0d9873e9944a | 8 |
| 198555 | capsaicin 0.025 % Topical Cream | SY | c5915c84-84a2-46f6-9f97-0d9873e9944a | 8 |
| 198555 | capsaicin 0.025 % Topical Cream | PSN | 7c733a30-5002-49e7-a6bd-7737a1d2461e | 4 |
| 198555 | capsaicin 0.25 MG/ML Topical Cream | SCD | 7c733a30-5002-49e7-a6bd-7737a1d2461e | 4 |
| 198555 | capsaicin 0.025 % Topical Cream | SY | 7c733a30-5002-49e7-a6bd-7737a1d2461e | 4 |
| 198555 | capsaicin 0.025 % Topical Cream | PSN | fd90a67d-d60d-a849-e053-6394a90a2cc8 | 2 |
| 198555 | capsaicin 0.025 % Topical Cream | PSN | 1dab5315-5027-57ad-e054-00144ff8d46c | 2 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | PSN | 1dab5315-5027-57ad-e054-00144ff8d46c | 2 |
| 198555 | capsaicin 0.25 MG/ML Topical Cream | SCD | 1dab5315-5027-57ad-e054-00144ff8d46c | 2 |
| 198555 | capsaicin 0.25 MG/ML Topical Cream | SCD | fd90a67d-d60d-a849-e053-6394a90a2cc8 | 2 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | SCD | 1dab5315-5027-57ad-e054-00144ff8d46c | 2 |
| 198555 | capsaicin 0.025 % Topical Cream | SY | 1dab5315-5027-57ad-e054-00144ff8d46c | 2 |
| 198555 | capsaicin 0.025 % Topical Cream | SY | fd90a67d-d60d-a849-e053-6394a90a2cc8 | 2 |
| 198555 | capsaicin 0.025 % Topical Cream | PSN | 7d77048b-b0b2-9ef8-e053-2991aa0a6a8f | 1 |
| 198555 | capsaicin 0.025 % Topical Cream | PSN | 7c14a409-88c5-4b9d-80a4-f9f80c64ebbf | 1 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | PSN | 7c14a409-88c5-4b9d-80a4-f9f80c64ebbf | 1 |
| 198555 | capsaicin 0.25 MG/ML Topical Cream | SCD | 7c14a409-88c5-4b9d-80a4-f9f80c64ebbf | 1 |
| 198555 | capsaicin 0.25 MG/ML Topical Cream | SCD | 7d77048b-b0b2-9ef8-e053-2991aa0a6a8f | 1 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | SCD | 7c14a409-88c5-4b9d-80a4-f9f80c64ebbf | 1 |
| 198555 | capsaicin 0.025 % Topical Cream | SY | 7d77048b-b0b2-9ef8-e053-2991aa0a6a8f | 1 |
| 198555 | capsaicin 0.025 % Topical Cream | SY | 7c14a409-88c5-4b9d-80a4-f9f80c64ebbf | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0536-2525-25 | 00536252525 | 1 TUBE in 1 CARTON (0536-2525-25) / 60 g in 1 TUBE | 1 tube | 2012-03-01 | 0000-00-00 | No | No | Current |