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 |
|---|---|---|---|---|---|---|
| Medi-First Hydrocortisone 1% | HYDROCORTISONE ACETATE 1% | Unifirst First Aid Corporation | f2b46d69-1c21-5ae9-e053-2a95a90a60a9 | 2025-10-24 | Warnings | M017 |
| Extra Strength | MENTHOL AND METHYL SALICYLATE | Saje Natural Business Inc. | 87d872b3-3231-d0f2-e053-2995a90a9d98 | 2025-10-24 | Warnings | M017 |
| Coralite Muscle and Joint Pain Relief | CAMPHOR, MENTHOL, AND MEHTYL SALICYLATE | United Exchange Corporation | 78edeeb8-3e3c-64bb-e053-2a91aa0a7bbc | 2025-10-24 | Warnings | M017 |
| Coralite Odor Free Pain Relief | LIDOCAINE | United Exchange Corporation | 7966d9f2-22f9-a900-e053-2991aa0aba55 | 2025-10-24 | Warnings | M017 |
| Signature Care Cold and Hot | MENTHOL, AND METHYL SALICYLATE | Safeway Inc. | ab201023-e3dc-52ec-e053-2995a90a1f18 | 2025-10-24 | Warnings | M017 |
| HealthWise Medicated Cold Hot 5% Patch | MENTHOL | Veridian Healthcare | 15aef56f-cd25-05ac-e063-6394a90a07bb | 2025-10-23 | Warnings | M017 |
| Alivio | LIDOCAINE | Amerise Pharmaceuticals LLC | eb3a98f1-c875-4f08-8b4b-44e22626b609 | 2025-10-23 | Warnings | M017 |
| Pain Relieveing Gel-Patch | LIDOCAINE | Bullet point LLC | 41d507c4-ad37-2686-e063-6394a90aae5b | 2025-10-23 | Warnings | M017 |
| ActivICE | MENTHOL | Medline Industries, LP | 98fa9a34-0e1e-0997-e053-2a95a90ac77d | 2025-10-23 | Warnings | M017 |
| Coralite Pain Relief Hot | MENTHOL AND CAPSAICIN | United Exchange Corporation | 78eb133d-01bb-6466-e053-2991aa0accc0 | 2025-10-23 | Warnings | M017 |
| Americaine | BENZOCAINE | Insight Pharmaceuticals LLC | 4fd14452-0285-40c4-b835-36935c2056b2 | 2025-10-23 | Warnings | M017 |
| zourunan PAIN RELIEF | PAIN RELIEF | Guchutang Biotechnology (Longyan) Co., Ltd | 41bc1c0c-63d5-0d41-e063-6394a90a341b | 2025-10-22 | Warnings | M017 |
| zourunan PAIN RELIEF | PAIN RELIEF | Guchutang Biotechnology (Longyan) Co., Ltd | 41bd0769-6ba0-d0d5-e063-6294a90af7c9 | 2025-10-22 | Warnings | M017 |
| Coralite Extra Strength Pain Relief Sleeve Knee | MENTHOL | United Exchange Corp. | aa5873bd-af64-41cc-8f16-7714c56bca96 | 2025-10-22 | Warnings | M017 |
| Family Care Muscle Rub | CAMPHOR, MENTHOL, AND METHYL SALICYLATE | United Exchange Corp. | 63006bb5-76e8-eb64-e053-2991aa0a95ad | 2025-10-22 | Warnings | M017 |
| Winco Cold and Hot Medicated Patch Large | MENTHOL | WINCO FOODS, LLC | af0d86c4-f74e-2dbe-e053-2a95a90a74c1 | 2025-10-22 | Warnings | M017 |
| Coralite Cold and Hot | MENTHOL | United Exchange Corp. | 064a6149-a0e2-8a73-e063-6394a90a7953 | 2025-10-22 | Warnings | M017 |
| Topical Analgesic | MENTHOL | Youngevity International Inc. | b4693947-f5b3-6fd3-e053-2995a90ab581 | 2025-10-22 | Warnings | M017 |
| PAIN RELIEVING | LIDOCAINE | Medhome Pharma Inc | 41cb1135-84e0-0c9a-e063-6294a90ada96 | 2025-10-22 | Warnings | M017 |
| KINKAN | AMMONIA, CAMPHOR (NATURAL), MENTHOL | KINKANDO CO., LTD . | f2c0f3e1-792b-4798-bf6d-acd1bbefa261 | 2025-10-21 | 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 |