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 |
|---|---|---|---|---|---|---|
| CVS Pain Relief | MENTHOL 10.5% | CVS | d0ea80ce-38b2-acde-e053-2995a90a47e5 | 2025-03-31 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE | A2A Integrated Pharmaceuticals, LLC | 31431866-6fb5-2acd-e063-6294a90ac520 | 2025-03-31 | Warnings | M017 |
| Citrus Cleansing Foot Soak and Body Soak | CAMPHOR | SANSAR, LLC | f136616d-9f32-4e55-a495-b7466fd68526 | 2025-03-28 | Warnings | M017 |
| Zpol ULTRA | MENTHOL, METHYL SALICYLATE | Laboratorios Zepol S.A. | 1a1433a6-8d04-96df-e063-6394a90a987b | 2025-03-27 | Warnings | M017 |
| Muscle Recovery Foot Soak and Body Soak | CAMPHOR | SANSAR, LLC | 1c347267-b653-41bf-9967-7feff17c38af | 2025-03-27 | Warnings | M017 |
| Soothing Lavender Foot Soak and Body Soak | CAMPHOR | SANSAR, LLC | ef26523a-b2f2-466e-89ad-f293cd64decb | 2025-03-27 | Warnings | M017 |
| Achelon Lidocaine Patch | LIDOCAINE PATCH 4% | Achelon, Inc | 31408e21-e58d-6db5-e063-6294a90aa4bc | 2025-03-26 | Warnings | M017 |
| Achelon Lidocaine Patch | LIDOCAINE PATCH 4% | Achelon, Inc | 3143bb72-2969-d66e-e063-6294a90a4604 | 2025-03-26 | Warnings | M017 |
| Parche Leon | CAPSAICIN, CAMPHOR, MENTHOL | Pharmadel LLC | a8f266fa-6e43-559e-e053-2995a90a2c75 | 2025-03-26 | Warnings | M017 |
| Adellina Numbing Cream | LIDOCAINE | Guangzhou Haishi Biological Technology Co., Ltd. | 314a83fe-8bdb-766f-e063-6294a90a61c6 | 2025-03-26 | Warnings | M017 |
| HealthWise Lidocaine Plus Menthol Patch | LIDOCAINE AND MENTHOL | Veridian Healthcare | 312f15fe-9297-2dc2-e063-6294a90a6f4d | 2025-03-25 | Warnings | M017 |
| HealthWise Lidocaine Patch | LIDOCAINE 4% | Veridian Healthcare | 3130729d-1679-90cd-e063-6294a90a21e6 | 2025-03-25 | Warnings | M017 |
| HealthWise Lidocaine Patch | LIDOCAINE 4% | Veridian Healthcare | 31314dda-6199-574d-e063-6394a90aae7a | 2025-03-25 | Warnings | M017 |
| RWSEFK Lidocaine Pain Relief Gel-Patch | LIDOCAINE PAIN RELIEF GEL-PATCH | Henan Enokon Medical Instrument Co., Ltd. | 31366793-f8a6-a2c4-e063-6294a90acbfc | 2025-03-25 | Warnings | M017 |
| Forticept Wounds and Burns Hydrogel | BENZETHONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE | Lidan, inc. | c6f58b63-9838-4ff4-8b1a-de2d41d6cf5f | 2025-03-25 | Warnings | M017 |
| MQ Pain Relieving Patch | PAIN RELIEVING PATCH | Zhengzhou Miaoqi Pharmaceutical Technology Co., Ltd | 0978ff22-c357-e266-e063-6394a90a98a4 | 2025-03-24 | Warnings | M017 |
| LidoPro Patch (Lidocaine 4%, Menthol 1%) | LIDOCAINE AND MENTHOL PATCH | Advanced Rx of Tennessee, LLC | 30c97646-db06-df84-e063-6394a90a7743 | 2025-03-20 | Warnings | M017 |
| Carmex Classic Lip Balm Medicated | CAMPHOR (SYNTHETIC), PETROLATUM | Carma Laboratories, Inc. | fb6eb93b-7dc0-4b6f-bfe1-1a7b47588e57 | 2025-03-20 | Warnings | M017 |
| Carmex Variety Pack Classic Medicated Lip Balm Daily Care Lip Balm SPF | CAMPHOR (SYNTHETIC), WHITE PETROLATUM OCTINOXATE, OXYBENZONE, AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Carma Laboratories, Inc. | 5f904369-5f21-4907-98de-df23bce30823 | 2025-03-20 | Warnings | M017 |
| DermaCort Anti-itch | HYDROCORTISONE | Melaleuca, Inc. | 24044b0f-dd1e-4762-82b8-7a28b08c2f77 | 2025-03-20 | 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 |