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 |
|---|---|---|---|---|---|---|
| AMRUTANJAN RELIEF PAIN BALM | CAMPHOR , MENTHOL, METHYL SALICYLATE | AMRUTANJAN HEALTH CARE LIMITED | ddee6714-8b18-4d87-944b-8467fda22e6b | 2025-07-23 | Warnings | M017 |
| Stopain Extra Strength Gel | MENTHOL | Troy Manufacturing, Inc. | 8bb89002-d7a2-4bee-b5a5-1fd1949273ef | 2025-07-22 | Warnings | M017 |
| Hielo Ardiente | MENTHOL | Menper Distributors, Inc. | 97ec516c-d2bc-47ce-82fe-bd68445d9570 | 2025-07-22 | Warnings | M017 |
| La Flecha Japonesa | METHYL SALICYLATE | Menper Distributors, Inc. | 08819ad0-97c2-49bd-b923-535b94a27167 | 2025-07-22 | Warnings | M017 |
| Veneno de Abeja Aceite De Vibora Brand | METHYL SALICYLATE | Menper Distributors Inc. | ad940dc8-9403-44cf-aed3-6e538cbe488b | 2025-07-22 | Warnings | M017 |
| Balsamo de Vaca Mascura | METHYL SALICYLATE | Menper Distributors Inc. | 321b6f1f-c802-4b96-99d3-e77217da11a3 | 2025-07-22 | Warnings | M017 |
| Abejas y Viboras Roll On | METHYL SALICYLATE | Menper Distributors Inc. | bedf3b36-7def-099f-e053-2a95a90ac15b | 2025-07-22 | Warnings | M017 |
| HealthWise Flexible 4% Lidocaine Patch | LIDOCAINE 4% | Veridian Healthcare | 3869cc18-5494-6142-e063-6394a90a75e5 | 2025-07-22 | Warnings | M017 |
| Arthcal 4% Lidocaine Patches | LIDOCAINE | Beijing JUNGE Technology Co., Ltd. | 2e531194-67ad-c645-e063-6394a90a916c | 2025-07-22 | Warnings | M017 |
| AMRUTANJAN RELIEF STRONG PAIN BALM | MENTHOL, METHYL SALICYLATE | AMRUTANJAN HEALTH CARE LIMITED | 206d8c1e-eb5b-4ec7-a54e-8defc9fb9d27 | 2025-07-22 | Warnings | M017 |
| Cold Sore Fast-Acting Pain Relief | GLYCERIN AND LIDOCAINE | Blistex Inc. | c7511322-dd6c-441c-bf7d-ad4f0c14956a | 2025-07-22 | Warnings | M017 |
| Mountain Ice Sports Pain Relief | MENTHOL, CAMPHOR | Mountainside Medical Equipment, Inc. | c1f5512c-67b1-4ff0-b1a5-616e883d436f | 2025-07-21 | Warnings | M017 |
| Stopain Clinical Roll-On | MENTHOL, UNSPECIFIED FORM | Troy Manufacturing, Inc. | 27703209-fdac-4620-a445-d89a84bc853d | 2025-07-21 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE | STRATEGIC SOURCING SERVICES LLC | 9bac1869-8072-49bd-8568-a87a184d2200 | 2025-07-21 | Warnings | M017 |
| Dr Kevin Khalili Pain Relief Cream | MENTHOL | DR. KHALILI LLC | 3a79b38c-9adc-60dd-e063-6394a90a5b30 | 2025-07-21 | Warnings | M017 |
| ARTHRITIS PAIN RELIEF | CAMPHOR, CAPSAICIN, METHYL SALICYLATE | YUNNAN BAIYAO GROUP CO., LTD. | 671c57f0-3c6f-4416-bc81-f6930fef327b | 2025-07-21 | Warnings | M017 |
| GoodSense Cooling Pain Relief | MENTHOL | Geiss, Destin & Dunn, Inc | 2e5e1375-df07-9a43-e063-6394a90a9938 | 2025-07-20 | Warnings | M017 |
| Benadryl Extra Strength Itch Cooling | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Kenvue Brands LLC | a7eae5dc-9db6-4bdf-9179-76060e75e044 | 2025-07-18 | Warnings | M017 |
| Nicotine Patches | NICOTINE PATCHES | Shenzhen TeLaFaErJiaLuo Technology Co., Ltd. | 3a1abd26-c0aa-8a65-e063-6294a90ab66e | 2025-07-17 | Warnings | M017 |
| Aouiv 4% Lidocaine Numbing Cream | 4% LIDOCAINE NUMBING CREAM | Guangzhou Qiexiran Cosmetics Co., Ltd. | 3a221dd2-e945-bd0e-e063-6294a90a8fb9 | 2025-07-17 | 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 |