NDC 0378-9124-16 - FENTANYL
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
- 0378-9124
- Requested NDC
- 0378-9124-16
- Package NDCs from labels
- 0378-9124-16, 0378-9124-98
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Effective date
- 2025-12-15
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| FENTANYL - Mylan Pharmaceuticals Inc. | Mylan Pharmaceuticals Inc. | 2025-12-15 | HUMAN PRESCRIPTION DRUG LABEL |
| Fentanyl - Lake Erie Medical DBA Quality Care Products LLC | Lake Erie Medical DBA Quality Care Products LLC | 2019-10-22 | HUMAN PRESCRIPTION DRUG LABEL |
| Fentanyl - Physicians Total Care, Inc. | Physicians Total Care, Inc. | 2009-12-16 | HUMAN PRESCRIPTION DRUG LABEL |
| National Council for Prescription Drug Programs indexing - billing unit | National Council for Prescription Drug Programs | 2012-07-24 | Indexing - Billing Unit |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0378-9124-16 | FENTANYL | 1 in 1 POUCH | PATCH | 1 | 27 | |
| 0378-9124-16 | FENTANYL | 72 h in 1 PATCH | PATCH | 72 | 27 | |
| 0378-9124-98 | FENTANYL | 5 in 1 CARTON | PATCH | 5 | 27 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0378-9124-16 | EA - Each | 0378-9124 | f642fe72-09eb-4ed4-8263-249306f8ca51 | 1 | 2012-07-24 |
| 0378-9124-98 | EA - Each | 0378-9124 | 9f18f012-f3bd-4078-ac89-99416e321909 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| Gas Relief Extra Strength | SIMETHICONE | TOP CARE (Topco Associates LLC) | ed8a723a-7dac-4670-8f02-f4154e0a36c9 | 2026-03-02 | Warnings | 92RU3N3Y1O |
| anti diarrheal anti gas | LOPERAMIDE HYDROCHLORIDE, SIMETHICONE | HyVee Inc | 396ea4f5-5c3d-4cbc-acd5-09eb64c806e0 | 2026-03-02 | Warnings | 92RU3N3Y1O |
| Fentanyl system | FENTANYL | ALVOGEN | 242759ef-cb6d-4e3e-9f8d-5e31efa1f289 | 2026-03-02 | Boxed warning, Warnings, Adverse reactions | 197696 245136 577057 245135 245134 UF599785JZ |
| Daily Moisturizing | DIMETHICONE | The Kroger Co. | ea8b186c-82d5-4552-bcce-03e56023ea99 | 2026-02-27 | Warnings, Adverse reactions | 92RU3N3Y1O |
| Rapid Repair Healing Cream | ALLANTOIN, DIMETHICONE | June Jacobs Labs LLC | 186c13be-5e41-b9c9-e063-6294a90ad574 | 2026-02-26 | Warnings | 92RU3N3Y1O |
| Dimethicone | DIMETHICONE | H E B | a8ad595a-c811-4534-82e0-9a01085b4b1e | 2026-02-24 | Warnings, Adverse reactions | 92RU3N3Y1O |
| Extra Strength Gas Relief | SIMETHICONE | Shield Pharmaceuticals Corp | fafb57da-0682-475e-8ff9-17f2182129ef | 2026-02-24 | Warnings | 92RU3N3Y1O |
| Oatmeal | DIMETHICONE | Better Living Brands, LLC | d28c5a60-0597-424f-bf7f-08dca39b22f5 | 2026-02-23 | Warnings, Adverse reactions | 92RU3N3Y1O |
| Dimethicone | DIMETHICONE | Meijer, Inc. | 75b91b97-ea84-4c4d-9e58-5a9ff27a778c | 2026-02-19 | Warnings, Adverse reactions | 92RU3N3Y1O |
| Daily Moisturizing | DAILY MOISTURIZING | Meijer, Inc. | 44949b46-70f2-4e52-adba-a8455da614eb | 2026-02-19 | Warnings, Adverse reactions | 92RU3N3Y1O |
| Daily Moisturizing | DIMETHICONE | Valu Merchandisers Company | 0cccadd7-11f3-5d1f-e063-6294a90a55c4 | 2026-02-16 | Warnings, Adverse reactions | 92RU3N3Y1O |
| Dimethicone | DIMETHICONE | Topco Associates LLC | f37f17f7-f084-4b74-8361-178d2315a476 | 2026-02-13 | Warnings, Adverse reactions | 92RU3N3Y1O |
| Daily Moisturizing | DIMETHICONE | Topco Associates LLC | 47e54eee-70e0-4bfa-ae77-d61a6560a9e1 | 2026-02-13 | Warnings, Adverse reactions | 92RU3N3Y1O |
| TEENY TUMMY Gas Relief Drops | SIMETHICONE | ALTANTIC BIOLOGICAS CORP. | 05eadb73-4468-4dae-a67b-133d893feed2 | 2026-02-13 | Warnings | 92RU3N3Y1O |
| Gas Relief | SIMETHICONE 180 MG | Pioneer Life Sciences, LLC | f5284b68-f167-41d4-8b2f-ae7bafae0f4c | 2026-02-13 | Warnings | 92RU3N3Y1O |
| Daily Moisturizing | DIMETHICONE | Retail Business Services, LLC | c8a876e2-0a34-4c3d-a0bc-549dd3048e8a | 2026-02-06 | Warnings, Adverse reactions | 92RU3N3Y1O |
| Daily Moisturizing | DIMETHICONE | Publix Super Markets, Inc. | 28ac9de4-2a63-4839-bed5-9bcc59ebeb2a | 2026-02-05 | Warnings, Adverse reactions | 92RU3N3Y1O |
| Daily Moisturizing | DIMETHICONE | Lidl US, LLC | c82f236d-c27f-458c-bcd8-19877d09e9a3 | 2026-02-04 | Warnings, Adverse reactions | 92RU3N3Y1O |
| Daily Moisturizing | DIMETHICONE | Lidl US, LLC | 5e83811f-773f-43e7-bab8-f9e558fb0e00 | 2026-02-04 | Warnings, Adverse reactions | 92RU3N3Y1O |
| Daily Moisturizing | DIMETHICONE | CVS Pharmacy, Inc. | edc20df4-561e-486f-b9f1-900672a0f2a4 | 2026-02-03 | Warnings, Adverse reactions | 92RU3N3Y1O |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.