Nicotine Patches
- Product NDC
- 85333-003
- 11-digit product format
- 853330003
- Labeler code
- 85333
- Product ID
- 85333-003_4c1d00b3-313c-933f-e063-6294a90ac46f
- 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
- 2026-03-03
- Substance
- NICOTINE
- Active strength
- 21 mg/21mg
- 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 | 21 mg/21mg |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 6M3C89ZY6R | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 198030 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4c1d00b3-313b-933f-e063-6294a90ac46f | 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 |
|---|---|---|---|---|---|---|
| 85333-003-02 | Nicotine Patches | 21 mg in 1 PATCH | PATCH | 21 | 1 | |
| 85333-003-02 | 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 |
|---|---|---|---|---|---|---|
| EltaMD Laser Balm | PETROLATUM SKIN PROTECTANT | CP Skin Health Group, Inc | 1c67ce72-89d9-4c4f-a9b0-28b7e67d30eb | 2023-11-09 | Warnings | M016 |
| DiaperDerm Diaper Rash | ZINC OXIDE | Diaperderm Inc | 4e1fce3e-c2b7-42da-9953-1dbb13e2467c | 2023-11-06 | Warnings | M016 |
| Doctors Diaper Rash Cream | ZINC OXIDE | DOCTOR'S DIAPER RASH CREAM, INC | 0988ccb1-7881-4d97-bcbf-d0cf4316e4be | 2023-11-06 | Warnings | M016 |
| DERMOIA Manuka Honey Eczema Cream | OATMEAL | TREASUREWISE LLC | a48e52a3-b681-4489-a1fd-6b09d8bc9c55 | 2023-11-06 | Warnings | M016 |
| GL HEALTH Barrier Skin Protectant | ZINC OXIDE | GL HEALTH, INC. | 76cfa330-fea9-48d4-b187-469154765d39 | 2023-11-06 | Warnings | M016 |
| Skin-lube | PETROLATUM, DIMETHICONE | The Hygenic Company, LLC. | d1005dec-04f6-3f88-e053-2a95a90ad9cb | 2023-11-05 | Warnings | M016 |
| Dr. Sheffield Anti Itch Cream | ANTI ITCH CREAM | Sheffield Pharmaceuticals LLC | 77f0593e-f694-4c02-9fd9-ad56ff2a920c | 2023-10-30 | Warnings | M016 |
| calahist | CALAMINE AND PRAMOXINE HYDROCHLORIDE | WALGREEN COMPANY | fed45e06-cc53-fbc5-e053-6294a90a1b19 | 2023-10-27 | Warnings | M016 |
| calahist clear | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE | WALGREEN COMPANY | fed469c2-fe13-6726-e053-6394a90a5f51 | 2023-10-27 | Warnings | M016 |
| Dr. Sayman Salve | SALVE | Sheffield Pharmaceuticals LLC | 18bdcd0c-9c81-47e1-ae24-2239ff8fd066 | 2023-10-24 | Warnings | M016 |
| Theriac Advanced Healing | LANOLIN | Sheffield Pharmaceuticals LLC | c780cd27-dc9e-45f3-97f0-e59b1b6b955a | 2023-10-24 | Warnings | M016 |
| Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash | ZINC OXIDE | Babo Botanicals, Inc. | d66e369e-9b19-b084-e053-2995a90aa259 | 2023-10-23 | Warnings | M016 |
| Babo Botanicals Sensitive Baby Healing | COLLOIDAL OATMEAL | Babo Botanicals, Inc. | 08659a5c-2d10-2f98-e063-6394a90a7760 | 2023-10-23 | Warnings | M016 |
| White Rose Petroleum Jelly | PETROLATUM | J. Strickland & Co. | 1aeb090d-c103-4c2e-accc-d9d248315db9 | 2023-10-21 | Warnings | M016 |
| Tricalm Hydrogel | ALUMINUM ACETATE | MODULAR THERMAL TECHNOLOGIES LLC DBA LIFE WEAR TECHNOLOGIES | 082c6441-be47-4466-e063-6394a90ad500 | 2023-10-20 | Warnings | M016 |
| Empower | WHITE PETROLATUM, ZINC OXIDE | Bemis Manufacturing Company Inc | 08006b60-966b-155b-e063-6294a90a206a | 2023-10-18 | Warnings | M016 |
| ANUBISMED | HA HYALURONIC | ANUBIS COSMETICS SL | eac771e2-4c1b-3808-e053-2995a90ac5fc | 2023-09-05 | Warnings | M016 |
| AnubisMed | SODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, IMIDAZOLIDINYL UREA | ANUBIS COSMETICS SL | ebf4b3ab-34e1-185a-e053-2a95a90ace3a | 2023-09-05 | Warnings | M016 |
| Anubis Barcelona | GLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICE | ANUBIS COSMETICS SL | eb651769-4d98-2b3b-e053-2a95a90a36b0 | 2023-09-01 | Warnings | M016 |
| Anubis Barcelona | DMAE | ANUBIS COSMETICS SL | f22b212d-d21d-5984-e053-2995a90a683e | 2023-09-01 | Warnings | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198030 | nicotine 21 MG/Day 24HR Transdermal System | PSN | 4c1d00b3-313b-933f-e063-6294a90ac46f | 1 |
| 198030 | 24 HR nicotine 0.875 MG/HR Transdermal System | SCD | 4c1d00b3-313b-933f-e063-6294a90ac46f | 1 |
| 198030 | nicotine 0.875 MG/HR 24HR Transdermal Patch | SY | 4c1d00b3-313b-933f-e063-6294a90ac46f | 1 |
| 198030 | nicotine 21 MG per 24HR 1 Day Transdermal Patch | SY | 4c1d00b3-313b-933f-e063-6294a90ac46f | 1 |
| 198030 | nicotine 21 MG/Day 24HR Transdermal System | SY | 4c1d00b3-313b-933f-e063-6294a90ac46f | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85333-003-02 | 85333000302 | 14 PATCH in 1 BOX (85333-003-02) / 21 mg in 1 PATCH | 14 patch | 2026-03-03 | No | No | Current |