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 |
|---|---|---|---|---|---|---|
| Lidocaine-Pain-Relief-Patch | LIDOCAINE-PAIN-RELIEF-PATCH | Henan Enokon Medical Instrument Co., Ltd. | 3ecfa867-50f6-d98a-e063-6394a90aefa0 | 2025-09-14 | Warnings | M017 |
| Meijer Hydrocortsione Cream | HYDROCORTSIONE CREAM 1% | Meijer Distribution Inc. | 1cbddb7e-f2e3-0951-e063-6394a90a3d37 | 2025-09-12 | Warnings | M017 |
| JO Prolonger with Benzocaine | BENZOCAINE | CC Wellness LLC | d955f612-1267-f1be-e053-2995a90a5345 | 2025-09-12 | Warnings | M017 |
| JO for Him Prolonger with Lidocaine | LIDOCAINE | CC Wellness LLC | b12dc6a3-142d-3219-e053-2995a90aead0 | 2025-09-12 | Warnings | M017 |
| Walgreens Medicated Foot Powder | MENTHOL | Davion, Inc | 58e1e7f7-6284-411f-9765-0e63eabca0f3 | 2025-09-12 | Warnings | M017 |
| PAIN RELIEF PATCHES | LIDOCAINE | Amerisource Bergen | 614f1e56-891f-4620-be10-0c075a1dbc3f | 2025-09-11 | Warnings | M017 |
| Industrial Itch and Pain Relief | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | R & R Lotion, Inc | 236415fc-f923-4a82-b54a-ecaf666dd2e0 | 2025-09-11 | Warnings | M017 |
| Eco Lips Menthol Medicated Lip Balm | MENTHOL | Eco Lips, Inc. | fc4c25d6-6109-dfd8-e053-6394a90a4e91 | 2025-09-10 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE 1% | Encube Ethicals, Inc. | d6f5c0df-6262-4704-bb24-430f66bb2ca8 | 2025-09-09 | Warnings | M017 |
| Blue-Emu Lidocaine Pain Relief Cream | LIDOCAINE CREAM 4% | Kingsway Pharmaceuticals dba NFI, LLC | 592811f2-e21c-6a58-e053-2991aa0a69a9 | 2025-09-09 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE | Unifirst First Aid Corporation | 282ed5ef-8c2a-4092-9d99-1a7eee7a39e3 | 2025-09-09 | Warnings | M017 |
| LubeLife Climax Control Delay | BENZOCAINE | CC Wellness LLC | e1a98e6d-0c24-75b8-e053-2a95a90ad136 | 2025-09-09 | Warnings | M017 |
| Blue-Emu Maximum Pain Relief | TROLAMINE SALICYLATE | Kingsway Pharmaceuticals dba NFI, LLC | c863351a-951b-4f7c-a9c0-4289d702054a | 2025-09-09 | Warnings | M017 |
| Tiger Balm Neck and Shoulder Rub | CAMPHOR (SYNTHETIC) AND MENTHOL | Haw Par Healthcare Ltd. | 02a65b25-78b2-4e29-9484-40e2228fb384 | 2025-09-09 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE | Unifirst First Aid Corporation | e90df2e5-2ef4-47dd-bd74-be9cea6d9d85 | 2025-09-08 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE | Unifirst First Aid Corporation | 69d6645e-db3c-4dc0-a9a5-e2bc963e2f28 | 2025-09-08 | Warnings | M017 |
| SupreH Arnica Bruise Cream | SUPREH ARNICA REMEDY PLUS BRUISE CREAM | Shenzhen Xinxin Yunhai Technology Co., Ltd. | 3e41fc0e-54c3-2622-e063-6294a90a13c9 | 2025-09-07 | Warnings | M017 |
| Menthol | MENTHOL | FlexiGo Inc | 3607c326-6db0-a2cd-e063-6394a90a9eb6 | 2025-09-06 | Warnings | M017 |
| TIDL PAIN RELIEF CRYOTHERAPY MENTHOL Cream | PAIN RELIEF CRYOTHERAPY MENTHOL CREAM | Shenzhen Sam Technology Co., Ltd. | 3e08cc87-2385-0838-e063-6394a90abf9b | 2025-09-05 | Warnings | M017 |
| TIDL CLINICAL CRYOTHERAPY MENTHOL Cream | CLINICAL CRYOTHERAPY MENTHOL CREAM | Shenzhen Sam Technology Co., Ltd. | 3e090b98-1db7-4174-e063-6394a90aa539 | 2025-09-05 | 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 |