NDC 83295-5050-01 - Xiclofen
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 83295-5050
- Requested NDC
- 83295-5050-01
- Package NDCs from labels
- 83295-5050-1, 83295-5050-01
- Manufacturer
- ASCLEMED USA INC. | ASCLEMED USA INC. DBA ENOVACHEM
- Effective date
- 2025-12-02
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Xiclofen - ASCLEMED USA INC. | ASCLEMED USA INC. DBA ENOVACHEM | ASCLEMED USA INC. | ASCLEMED USA INC. DBA ENOVACHEM | 2025-12-02 | HUMAN PRESCRIPTION DRUG LABEL |
| Xiclofen - STRAND HEALTH GROUP | STRAND HEALTH GROUP | 2025-05-21 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83295-5050-1 | Xiclofen | 85 g in 1 TUBE | OINTMENT | 85 | 2 | |
| 83295-5050-1 | Xiclofen | 1 in 1 BOX | OINTMENT | 1 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 83295-5050 | XICLOFEN (DICLOFENAC SODIUM, METHYL SALICYLATE) OINTMENT [STRAND HEALTH GROUP] | 2 | Current NDC, 2 package rows | 20250523_2d92d378-2e9c-f9d5-e063-6294a90ac715.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 83295-5050-1 | GM - Gram | 83295-5050 | 7067b793-28cb-4ef7-a531-6d7a58510617 | 1 | 2025-05-14 |
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 |
|---|---|---|---|---|---|---|
| La Vaquita New Regular | METHYL SALICYLATE | Delon Laboratories (1990) Ltd | d62186ac-afbb-443e-98c2-f0d122422a3c | 2026-09-01 | Warnings | LAV5U5022Y |
| La Vaquita New Extra | METHYL SALICYLATE, MENTHOL | Delon Laboratories (1990) Ltd | 3097a01b-cee5-492f-b65a-63992fb28e3a | 2026-09-01 | Warnings | LAV5U5022Y |
| Aloetouch Protect Fragrance Free | DIMETHICONE | Medline Industries, LP | 81f0071b-2bf3-455b-9e5d-8f3ca20adcdf | 2026-09-01 | Warnings | 92RU3N3Y1O |
| SILICONE SCAR | DIMETHICONE | Haikou Flash Purchase Star Cross-Border Trade Co., Ltd. | 5a7727d1-09d1-3cb3-e063-6294a90a1bc5 | 2026-09-01 | Warnings | 344S277G0Z 92RU3N3Y1O |
| Skin Smoothing Care | CENTELLA ASIATICA TRITERPENOIDS | Haikou Flash Purchase Star Cross-Border Trade Co., Ltd. | 5a77f521-2948-6c88-e063-6394a90ad18f | 2026-09-01 | Warnings | 344S277G0Z |
| Kroger Extra Strength | SIMETHICONE ANTIGAS | KROGER COMPANY | 67ddce93-4d68-4280-bf8b-337b91ab8c8f | 2026-09-01 | Warnings | 92RU3N3Y1O |
| Antiseptic | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | WALMART INC. (see also Equate) | ceb125d9-8c1b-498c-b0f0-f18756ede442 | 2026-09-01 | Warnings | LAV5U5022Y |
| Gas Relief | SIMETHICONE | United Natural Foods, Inc. dba UNFI | 011859d8-3d0f-4ca7-a98b-4150054154dc | 2026-09-01 | Warnings | 92RU3N3Y1O |
| Kroger Extra Strength Gas Relief | SIMETHICONE ANTIGAS | KROGER COMPANY | 6aa691e4-3179-4cf7-855a-e44f16904c1c | 2026-09-01 | Warnings | 92RU3N3Y1O |
| Diclofenac sodium and Misoprostol | DICLOFENAC SODIUM AND MISOPROSTOL | Mylan Pharmaceuticals Inc. | a7701e8c-4e16-4165-8b83-de2c08d5ded3 | 2026-08-31 | Boxed warning, Warnings, Adverse reactions | QTG126297Q |
| Diclofenac Sodium and Misoprostol | DICLOFENAC SODIUM AND MISOPROSTOL | Actavis Pharma, Inc. | df8b8660-0c24-4848-8bea-c1b935090c66 | 2026-08-31 | Boxed warning, Warnings, Adverse reactions | QTG126297Q |
| Infants Gas Relief Dye Free | SIMETHICONE ANTIGAS | THE KROGER CO. | 722c8226-6556-4150-9fda-91be2b31183f | 2026-08-31 | Warnings | 92RU3N3Y1O |
| Daily Moisturizing | DIMETHICONE | Your Military Exchanges | e7af5488-1c49-41e9-9d8b-d519c6107699 | 2026-08-28 | Warnings, Adverse reactions | 92RU3N3Y1O |
| Sinsinpas Arex Pain Relieving Patch, Medium | CAMPHOR, MENTHOL, METHYL SALICYLATE | Sinsin Pharmaceutical Co., Ltd. | 46453ef2-512b-4852-e063-6394a90a8912 | 2026-08-28 | Warnings | LAV5U5022Y |
| Sinsinpas arex patch large | CAMPHOR, MENTHOL, METHYL SALICYLATE | Sinsin Pharmaceutical Co., Ltd. | 47c242da-56cd-bea1-e063-6394a90a41de | 2026-08-28 | Warnings | LAV5U5022Y |
| GERI-LANTA MAXIMUM STRENGTH | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | Preferred Pharmaceuticals Inc. | 3b049027-30ac-4c78-a4f1-8191f7ed45bf | 2026-08-27 | Warnings | 92RU3N3Y1O |
| Medline | DIMETHICONE | Medline Industries, LP | 0d964138-f68d-dbf5-e063-6294a90a8320 | 2026-08-27 | Warnings | 92RU3N3Y1O |
| Extra Strength Gas Relief | SIMETHICONE | Shield Pharmaceuticals Corp | 534144be-fcaf-400d-b772-595c62ae6ea6 | 2026-08-27 | Warnings | 92RU3N3Y1O |
| Antacid | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE | Guardian Drug Company | 48ec50ab-f24b-367b-e063-6294a90ad736 | 2026-08-27 | Warnings | 92RU3N3Y1O |
| anti diarrheal and anti gas | LOPERAMIDE HYDROCHLORIDE, SIMETHICONE | CVS Pharmacy | 065699b5-217e-432f-a253-cea2d3f62233 | 2026-08-26 | Warnings | 92RU3N3Y1O |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.