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 |
|---|---|---|---|---|---|---|
| itch relief | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | H E B | 34c7bcd3-203f-4630-894d-3739a1576c8d | 2024-10-13 | Warnings | M017 |
| hydrocortisone | HYDROCORTISONE | H E B | 25ec9014-64c4-44df-9e67-9f9223ffc923 | 2024-10-12 | Warnings | M017 |
| PAIN RELIEF Gel-Roll On | LIDOCAINE AND MENTHOL | Shanghai Chuangshi Medical Technology (Group) Co., Ltd. | f02fa9c0-b8af-f362-e053-2a95a90ae516 | 2024-10-11 | Warnings | M017 |
| Insect Sting Relief Pad | BENZOCAINE, ALCOHOL | Hubei Changjian Medical Products Co., Ltd. | 6a269982-0e25-4c09-aef1-0b398bdc5ed4 | 2024-10-11 | Warnings | M017 |
| HYDROCORTISONE | HYDROCORTISONE | VIVE HEALTH LLC | 24221805-e5c9-5785-e063-6394a90a9d2f | 2024-10-10 | Warnings | M017 |
| De La Cruz Camphor | CAMPHOR | DLC Laboratories, Inc. | 62359237-de2d-4497-bfd6-36991cfc8acf | 2024-10-10 | Warnings | M017 |
| Anti Itch | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | Meijer Distribution Inc | 4f536a86-6419-4ab0-a7e8-5c37943823e2 | 2024-10-09 | Warnings | M017 |
| terrasil Bruise and Pain Relief Maximum Strength | CAMPHOR, MENTHOL | Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions | 240b231d-a8b2-c64c-e063-6394a90a7440 | 2024-10-09 | Warnings | M017 |
| Muscle Freeze Relief | MENTHOL | NATURAL ESSENTIALS, INC. | 815c534b-096d-49f2-b5f2-8c885d45a5e6 | 2024-10-09 | Warnings | M017 |
| HYDROCORTISONE | HYDROCORTISONE | VIVE HEALTH LLC | 2410dc2f-9332-19fa-e063-6394a90a2835 | 2024-10-09 | Warnings | M017 |
| CVS Health Lidocaine Pain-Relieving | LIDOCAINE | Natural Essentials, Inc. | fc23b2e2-4abc-4119-b8bd-305b4327f1dd | 2024-10-09 | Warnings | M017 |
| KERACARE | MENTHOL 1% | Avlon Industries, Inc. | f72eec6d-1204-4e03-8aed-d5bcf8d3bbce | 2024-10-09 | Warnings | M017 |
| Eagle Medicated | MENTHOL METHYL SALICYLATE | Eagle Indo Pharma, PT | da338796-de9c-be51-e053-2a95a90a2509 | 2024-10-07 | Warnings | M017 |
| Eagle Medicated | MENTHOL METHYL SALICYLATE | Eagle Indo Pharma | e2c5f821-cdd5-190d-e053-2a95a90a9159 | 2024-10-07 | Warnings | M017 |
| NanoXtreme Pain Relieving | MENTHOL, METHYL SALICYLATE | MG Science Technologies LLC | c1490c30-a9db-4120-adaf-9e8000169e46 | 2024-10-07 | Warnings | M017 |
| CAREALL Hydrocortisone Maximum Strength | HYDROCORTISONE | New World Imports, Inc | ea656cf8-cad5-4fa5-82e7-daec77a0bb04 | 2024-10-07 | Warnings | M017 |
| Eagle Medicated Oil Refreshing | MENTHOL, METHYL SALICYLATE | Eagle Indo Pharma, PT | e2729023-d689-7ae2-e053-2a95a90a78dc | 2024-10-06 | Warnings | M017 |
| Flanax Back Pain Relief | LIDOCAINE | Belmora LLC | 46d33346-e582-4af1-b81a-feca7033dceb | 2024-10-04 | Warnings | M017 |
| Muscle Balm | MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC) | Natural Essentials, Inc. | 16918ba3-2e07-4232-9ed3-4c7751796cd2 | 2024-10-04 | Warnings | M017 |
| Fast Freeze Pain Relieving Continuous | MENTHOL, UNSPECIFIED FORM | Natural Essentials, Inc. | 998a4824-9ed9-4fe0-b45b-72e52861fcd3 | 2024-10-04 | 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 |