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 |
|---|---|---|---|---|---|---|
| BENGAY Tropical Jasmine | LIDOCAINE | Kenvue Brands LLC | c416320a-c0d7-401e-b0fa-44114d76a557 | 2024-11-06 | Warnings | M017 |
| Bengay Ultra Strength Large Size | MENTHOL, UNSPECIFIED FORM | Kenvue Brands LLC | f57ccc33-400b-4401-a348-c54d1eb9f5d0 | 2024-11-06 | Warnings | M017 |
| Band Aid Antiseptic Cleansing To Go | BENZALKONIUM CHLORIDE, PRAMOXINE HCL | Kenvue Brands LLC | d5749cba-32f3-cf9c-e053-2a95a90a4416 | 2024-11-06 | Warnings | M017 |
| Pain Relieving Cream | CAMPHOR AND MENTHOL | GOLDEN TIGER DISTRIBUTION L.L.C. | 26473383-282c-fb10-e063-6394a90a5fa2 | 2024-11-06 | Warnings | M017 |
| Pain Relieving Cream | CAMPHOR AND MENTHOL | GOLDEN TIGER DISTRIBUTION L.L.C. | 1b6f929a-db65-8a02-e063-6394a90a8b59 | 2024-11-06 | Warnings | M017 |
| Meijer Maximum Strength Pain Relieving Analgesic | MENTHOL, UNSPECIFIED FORM | Meijer Distribution, Inc | bd6f04f9-a23b-45f6-bce2-1ef7203198e1 | 2024-11-06 | Warnings | M017 |
| Meijer Cold and Hot Pain Relieving Analgesic | LIDOCAINE HYDROCHLORIDE AND MENTHOL, UNSPECIFIED FORM | Meijer Distribution, Inc | 6d356563-9098-4994-8ad8-819a8033a9f4 | 2024-11-06 | Warnings | M017 |
| TopCare Maximum Strength Pain Relieving Analgesic | MENTHOL, UNSPECIFIED FORM | Topco Associates LLC | dc80d2f9-e3eb-4feb-bad5-7d6ab107f9ab | 2024-11-05 | Warnings | M017 |
| Aveeno Restorative Skin Therapy Itch Relief Balm | PRAMOXINE HYDROCHLORIDE | Kenvue Brands LLC | 61824ca7-a2d3-4830-b2bb-149a3222bfc8 | 2024-11-05 | Warnings | M017 |
| Aveeno Hydrocortisone ANTI-ITCH | HYDROCORTISONE | Kenvue Brands LLC | 233de4d7-e533-40cd-a5ed-e8b09abc626e | 2024-11-05 | Warnings | M017 |
| STING MASTER | LIDOCAINE HYDROCHLORIDE | Les Technologies Ptero, Inc | 94c6fd1f-9e74-420b-9d25-61b37953b838 | 2024-11-05 | Warnings | M017 |
| Alocane Emergency Burn | LIDOCAINE HYDROCHLORIDE | Quest Products, LLC. | 0c8e65a6-dff3-43b4-a3f1-95deb574ea89 | 2024-11-05 | Warnings | M017 |
| Alocane Max | LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE | Quest Products LLC | 0a35ac19-6883-a733-e063-6294a90ad22d | 2024-11-05 | Warnings | M017 |
| Alocane Plus | LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE | Quest Products, Inc. | cfe8114b-df65-064b-e053-2a95a90a33f6 | 2024-11-05 | Warnings | M017 |
| Alocane Botanicals | LIDOCAINE HYDROCHLORIDE | Quest Products, LLC. | 02a8e5c7-56f4-eb0d-e063-6294a90a80cd | 2024-11-05 | Warnings | M017 |
| Alocane Emergency Burn Pads | LIDOCAINE HYDROCHLORIDE | Quest Products, Inc. | fe58bb89-7216-4121-afd3-d1438bdfbfa2 | 2024-11-05 | Warnings | M017 |
| Licefreee AfterLice | PRAMOXINE HCI | Tec Laboratories Inc. | 06c4cc42-a215-3949-e063-6394a90a665e | 2024-11-05 | Warnings | M017 |
| Antibacterial Lidocaine Wound Gel | BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE | ASO LLC | cb9505b7-222d-3a24-e053-2a95a90a0b64 | 2024-11-05 | Warnings | M017 |
| TopCare Pain Relieving Analgesic | LIDOCAINE HYDROCHLORIDE | Topco Associates LLC | 6b4783e0-1987-4838-9e8c-b95426d62b28 | 2024-11-05 | Warnings | M017 |
| Eagle Green Balm | CAMPHOR MENTHOL | Borden Company (Private) Limited | 6f7a796b-a31c-0e60-e053-2a91aa0a022b | 2024-11-04 | 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 |