Nicotine Patches
- Product NDC
- 85333-005
- 11-digit product format
- 853330005
- Labeler code
- 85333
- Product ID
- 85333-005_4d46110b-5aa8-5261-e063-6394a90a423a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Patches
- Dosage form
- PATCH
- Route
- TRANSDERMAL
- Labeler
- Zhejiang FTA Shengzuozhi Biotechnology Co., LTD
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-03-18
- Substance
- NICOTINE
- Active strength
- 7 mg/7mg
- Pharmacologic classes
- Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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
- Nicotine Patches
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| NICOTINE | 7 mg/7mg |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 6M3C89ZY6R | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 198031 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4d46110b-5aa7-5261-e063-6394a90a423a | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85333-005-02 | Nicotine Patches | 21 mg in 1 PATCH | PATCH | 21 | 1 | |
| 85333-005-02 | Nicotine Patches | 14 in 1 BOX | PATCH | 14 | 1 |
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 |
|---|---|---|---|---|---|---|
| Diaper Rash | ZINC OXIDE | Target Corporation | 8059f489-f144-4de5-9454-ac6c1af35dd2 | 2026-02-18 | Warnings, Adverse reactions | M016 |
| Coconut Milk and Shea Petroleum Jelly | WHITE PETROLATUM | Target Corporation | c78d9864-92e0-4ad8-8a9b-9752ac6784e8 | 2026-02-18 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | Strategic Sourcing Services LLC | 043375b2-e636-4822-9e05-df2327d29986 | 2026-02-17 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | Strategic Sourcing Services LLC | 3ade1f7f-a870-4f77-96b9-f63bf4cdf5ae | 2026-02-17 | Warnings, Adverse reactions | M016 |
| Pure petroleum | WHITE PETROLATUM | Valu Merchandisers Company | 4113bb6e-070a-4116-a8d6-12c6b4475beb | 2026-02-16 | Warnings, Adverse reactions | M016 |
| Diaper Rash | ZINC OXIDE | Valu Merchandisers Company | e5465ddd-e38c-44a4-bb9b-3edbc636576d | 2026-02-16 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | Valu Merchandisers Company | 8b8decec-e921-4ff9-bb49-7e38e34724f6 | 2026-02-16 | Warnings, Adverse reactions | M016 |
| Daily Moisturizing | DIMETHICONE | Valu Merchandisers Company | 0cccadd7-11f3-5d1f-e063-6294a90a55c4 | 2026-02-16 | Warnings, Adverse reactions | M016 |
| Witch Hazel | WITCH HAZEL | Valu Merchandisers Company | 7c6fa37f-79b8-4409-b7a9-3f02332f887a | 2026-02-16 | Warnings, Adverse reactions | M016 |
| Diaper Rash | ZINC OXIDE | United Natural Foods, Inc. dba UNFI | 014d0028-486e-4f1c-a14f-8162e393ebca | 2026-02-16 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | United Natural Foods, Inc. dba UNFI | 29a3a719-5e8b-407d-b9d9-bdba26758292 | 2026-02-16 | Warnings, Adverse reactions | M016 |
| Diaper Rash | ZINC OXIDE | Topco Associates LLC | 8acb1b47-70ed-4aa2-a7c0-e807042affc7 | 2026-02-13 | Warnings, Adverse reactions | M016 |
| Calamine | FERRIC OXIDE RED | Topco Associates LLC | 2b32e720-ac71-4d60-bc06-e28a00f8a450 | 2026-02-13 | Warnings, Adverse reactions | M016 |
| Pure petroleum | WHITE PETROLATUM | Topco Associates LLC | 3babe2cf-9e6c-4f22-940f-c1fdf489f1c7 | 2026-02-13 | Warnings, Adverse reactions | M016 |
| Clear Anti Itch | PRAMOXINE HCL, ZINC ACETATE | Topco Associates LLC | 8d3d1ff5-4868-495d-807c-e45aa2176f63 | 2026-02-13 | Warnings, Adverse reactions | M016 |
| Healing | PETROLATUM | Topco Associates LLC | b929b159-4af5-4a03-8e7c-676a6ba2bf55 | 2026-02-13 | Warnings, Adverse reactions | M016 |
| Calamine | CALAMINE, PRAMOXINE HCL | Topco Associates LLC | 15d1ae3f-509c-4e6b-8f0c-cf9265680358 | 2026-02-13 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | Topco Associates LLC | cd7f1727-0b6e-4993-9820-43783994efa1 | 2026-02-13 | Warnings, Adverse reactions | M016 |
| Dimethicone | DIMETHICONE | Topco Associates LLC | f37f17f7-f084-4b74-8361-178d2315a476 | 2026-02-13 | Warnings, Adverse reactions | M016 |
| Baby Eczema Therapy | COLLOIDAL OATMEAL | Topco Associates LLC | 4f6af42c-f41e-455f-b94b-3793bf0b9a3f | 2026-02-13 | Warnings, Adverse reactions | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198031 | nicotine 7 MG/Day 24HR Transdermal System | PSN | 4d46110b-5aa7-5261-e063-6394a90a423a | 1 |
| 198031 | 24 HR nicotine 0.292 MG/HR Transdermal System | SCD | 4d46110b-5aa7-5261-e063-6394a90a423a | 1 |
| 198031 | nicotine 0.292 MG/HR 24HR Transdermal Patch | SY | 4d46110b-5aa7-5261-e063-6394a90a423a | 1 |
| 198031 | nicotine 7 MG per 24HR 1 Day Transdermal Patch | SY | 4d46110b-5aa7-5261-e063-6394a90a423a | 1 |
| 198031 | nicotine 7 MG/Day 24HR Transdermal System | SY | 4d46110b-5aa7-5261-e063-6394a90a423a | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85333-005-02 | 85333000502 | 14 PATCH in 1 BOX (85333-005-02) / 21 mg in 1 PATCH | 14 patch | 2026-03-18 | No | No | Current |