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 |
|---|---|---|---|---|---|---|
| ULTRA STRENGTH ZHENG GU SHUI | MENTHOL AND CAMPHOR | GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD | 53397663-044d-4e48-989b-2c6257af5f84 | 2025-07-14 | Warnings, Adverse reactions | M017 |
| TIGER BALM PAIN RELIEVING HYDROGEL | CAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUM | Haw Par Healthcare Ltd. | cb60037f-bceb-4090-a5e4-bdda0cbf9f5c | 2025-07-14 | Warnings | M017 |
| Avedana Hydrocortisone Cream with Aloe | HYDROCORTISONE | Unipack LLC | 2a55c426-39b4-4d94-b6b4-6c548c9685e9 | 2025-07-13 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE ACETATE | Rite Aid Corporation | cb6e0bed-2ea1-49d2-89e7-2554e7565b74 | 2025-07-11 | Warnings | M017 |
| QUALITY CHOICE Maximum Strength Lidocaine Pain Relief Roll On | LIDOCAINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION | 7b3ff4c1-0b60-4f7a-8aa4-c84b7c7137c4 | 2025-07-11 | Warnings | M017 |
| Antibiotic Plus Pain Relief | NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE | TARGET Corporation | 6fba5890-f48f-4302-a8ac-5087a6e03bd5 | 2025-07-11 | Warnings | M017 |
| TopCare Antibiotic Plus Pain Relief | NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE | Topco Associates LLC | 55dc4025-f07f-41b2-8b18-6a11ee04b5cc | 2025-07-11 | Warnings | M017 |
| Benadryl Extra Strength Itch Relief | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Kenvue Brands LLC | 309d9be0-e367-429a-a1fa-ab7855477c8a | 2025-07-10 | Warnings | M017 |
| Bengay Vanishing Scent | MENTHOL, UNSPECIFIED FORM | Kenvue Brands LLC | 6cc3294b-3b0f-44d0-af71-61db1022d269 | 2025-07-10 | Warnings | M017 |
| Cold Hot Medicated Patch 5% Menthol | MENTHOL | Quality Choice | ce544a7c-8dc6-4e63-b499-d8a4e0ec48c3 | 2025-07-10 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE ACETATE | Walgreen Company | bff322f1-59c3-41e0-8685-fcfe52bf4b42 | 2025-07-10 | Warnings | M017 |
| CVS Cortisone | HYDROCORTISONE | CVS Pharmacy | 87631be8-94b8-4718-858d-d2f30e636cce | 2025-07-10 | Warnings | M017 |
| TopCare Hydrocortisone Plus 12 Moisturizers | HYDROCORTISONE | Topco Associates LLC | c40e8e1d-d6d7-4880-99d3-011b97a5e4f3 | 2025-07-10 | Warnings | M017 |
| Live Better Hydrocortisone with Aloe | HYDROCORTISONE | The Great Atlantic & Pacific Tea Company | 044e6ee2-98a6-4802-b33d-78b8551356c4 | 2025-07-10 | Warnings | M017 |
| Rocainol TOPICAL ANALGESIC | METHYL SALICYLATE, MENTHOL | Compania Internacional de Comercio, S.A.P.I de C.V. | 827ec7b2-3d87-47e0-a47a-966b25732c32 | 2025-07-10 | Warnings | M017 |
| NumbR-X | LIDOCAINE HCL | Prodigy Media Inc | 16329ab6-4a33-4c38-85e0-5aad9c75d61d | 2025-07-10 | Warnings | M017 |
| Dr Lido | LIDOCAINE HCL | Prodigy Media Inc | da0938f0-00e7-4502-8721-d64c71f594fc | 2025-07-10 | Warnings | M017 |
| Pain Relief Patch | CAMPHOR, METHYL SALICYLATE, MENTHOL | CDMA, Inc. | da1ec2fe-cc37-4126-90a8-6eb4b8f2e57b | 2025-07-09 | Warnings | M017 |
| ORTHOGEL Menthol 3.5% | MENTHOL | LiquidCapsule Manufacturing LLC | 4fd4b7ac-1971-4abe-8fbb-74ab69e12061 | 2025-07-09 | Warnings | M017 |
| Good Neighbor Pharmacy Hydrocortisone Plus 12 Moisturizers | HYDROCORTISONE | AmerisourceBergen | f36acdb8-a526-4bb7-a557-e1dcbbc1cf45 | 2025-07-08 | 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 |