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 |
|---|---|---|---|---|---|---|
| Pain Itch Relief | LIDOCAINE HCI | Trifecta Pharmaceutical USA LLC | f40b19a8-795c-f514-e053-2a95a90a6d15 | 2024-12-20 | Warnings | M017 |
| Muscle Rub Cream | MENTHOL 10%, METHYL SALICYLATE 15% | Trifecta Pharmaceuticals USA, LLC. | 44d3638d-f29b-0e01-e054-00144ff88e88 | 2024-12-20 | Warnings | M017 |
| Rhuli Gel | CAMPHOR, MENTHOL | Trifecta Pharmaceuticals USA, LLC. | 4fbb3c23-ed47-336e-e054-00144ff8d46c | 2024-12-20 | Warnings | M017 |
| Hydrocortisone Cream with Aloe | HYDROCORTISONE | Rugby Laboratories | 132982ea-cce6-687c-e063-6294a90a4632 | 2024-12-20 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE 1% | Pharmacy Value Alliance LLC | 9bb98452-a605-5c20-e053-2995a90a1ea7 | 2024-12-20 | Warnings | M017 |
| DCH Cooling Pain Relief | MENTHOL 10.5% | Derma Care Research Labs, LLC | 00dcdae0-c744-8402-e063-6294a90a12f8 | 2024-12-20 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE 1% | Pharmacy Value Alliance LLC | ab95e606-69f0-1d58-e053-2a95a90a073b | 2024-12-20 | Warnings | M017 |
| Itch Relief Cream | ZINC ACETATE 0.1%, DIPHENHYDRAMINE HYDROCHLORIDE 2% | Pharmacy Value Alliance LLC | 37fe6d82-adee-4f58-e054-00144ff88e88 | 2024-12-20 | Warnings | M017 |
| Warrior First Aid Anti Itch | DIPHENHYDRAMINE HCL 2%, ZINC ACETATE 0.1% | Derma Care Research Labs, LLC | ec6e9a5b-c61d-a385-e053-2995a90ac936 | 2024-12-20 | Warnings | M017 |
| DCH Burn Relief | LIDOCAINE HCL | Derma Care Research Labs, LLC | ff227154-cf3b-9796-e053-6294a90a5535 | 2024-12-20 | Warnings | M017 |
| Outback Pain Relief | CAMPHOR 6%, MENTHOL 16% | Derma Care Research Labs, LLC | c238c930-2012-2d48-e053-2a95a90a8a4a | 2024-12-20 | Warnings | M017 |
| Meijer Pain Relief | LIDOCAINE HCL 4% | Meijer | f31b11ed-2ff9-5cfc-e053-2a95a90af2ca | 2024-12-20 | Warnings | M017 |
| Meijer Pain Relief | MENTHOL 10.5% | Meijer | bed81975-bd63-cf5b-e053-2995a90ac5fa | 2024-12-20 | Warnings | M017 |
| Mirakel Pain and Itch Relief | BENZOCAINE 20%, RESORCINOL 3% | Sanvio, Inc. | ed34d728-0275-e209-e053-2995a90a93ff | 2024-12-20 | Warnings | M017 |
| Meijer Pain Relief | LIDOCAINE 4% | Meijer | bed67c31-c479-6f9b-e053-2a95a90a5516 | 2024-12-20 | Warnings | M017 |
| Blue-Emu Ultra with Hemp Seed | TROLAMINE SALICYLATE | Kingsway Pharmaceuticals dba NFI, LLC | 80a3cf99-16e8-412b-ab9f-3d9d5cbb7aa9 | 2024-12-20 | Warnings | M017 |
| Epsom Salts | MAGNESIUM SULFATE | International Wholesale Inc. | e4d9bc32-ac85-349f-e053-2995a90a032f | 2024-12-19 | Warnings | M017 |
| Epsom Salts | MAGNESIUM SULFATE | International Wholesale Inc. | e5f3edc2-1b79-533a-e053-2a95a90ae9b6 | 2024-12-19 | Warnings | M017 |
| Leader | LIDOCAINE HCL | Cardinal Health | cea6bd2d-a265-1209-e053-2995a90ab0a5 | 2024-12-19 | Warnings | M017 |
| Rugby Anti-Itch | CAMPHOR, MENTHOL | RUGBY LABORATORIES | 99d8ad9e-46ec-15fc-e053-2995a90a0d17 | 2024-12-19 | 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 |