Nicotine Patches

Product NDC
85795-002
11-digit product format
857950002
Labeler code
85795
Product ID
85795-002_3a1abd26-c0ab-8a65-e063-6294a90ab66e
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Patches
Dosage form
PATCH
Route
TOPICAL
Labeler
Shenzhen TeLaFaErJiaLuo Technology Co., Ltd.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-07-17
Substance
NICOTINE
Active strength
21 mg/1001
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE21 mg/1001

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6M3C89ZY6RInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198030Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3a1abd26-c0aa-8a65-e063-6294a90ab66eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85795-002-01Nicotine Patches30 in 1 BOXPATCH301

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.

Matched openFDA labels page 103 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IKONIK TONIKLIDOCAINE HYDROCHLORIDEIKONIK CARE, LLC122fdfe8-b5fa-46d1-9fd9-3df9887ed3202025-01-14WarningsExact identifier
application number: M017
elp essential MANTECA DE UBREMETHYL SALICYLATE, CAMPHORMiramar Cosmetics, Inc DBA Miramar Labc3964dfe-17fe-4d89-a4c4-cf500f9822592025-01-13WarningsExact identifier
application number: M017
MethyltenMETHYL SALICYLATE 10%Puretek Corporation28f4093f-803f-0e70-e063-6294a90a98a42025-01-13WarningsExact identifier
application number: M017
Refill Bundle 7 Large OfficeBENZALKONIUM CHLORIDECMC Group, Inc.6620a8f3-098d-d045-e053-2a91aa0a0d942025-01-13WarningsExact identifier
application number: M017
Jakwork Numbing CreamNUMBING CREAMGuangzhou Zanming Trading Co., Ltd.2ba1de83-494a-6c54-e063-6294a90a9b2d2025-01-13WarningsExact identifier
application number: M017
Arthritis HotMENTHOL AND METHYL SALICYLATEChattem, Inc.cc57b9b6-8ba5-4ff3-a5df-97d8f5b1bebd2025-01-13WarningsExact identifier
application number: M017
Re-Lieved Lidocaine PatchLIDOCAINE PATCH 4%Transfer Technology00b40dda-53ad-0458-e063-6394a90aa8352025-01-11WarningsExact identifier
application number: M017
Re-Lieved Lidocaine PatchLIDOCAINE PATCH 4%Transfer Technology00b47eb7-6b43-d9e2-e063-6294a90a9a382025-01-11WarningsExact identifier
application number: M017
Re-Lieved 4% Lidocaine Fabric TapeLIDOCAINE 4% FABRIC TAPETransfer Technologye9a894b0-54f2-707e-e053-2a95a90a0f0d2025-01-11WarningsExact identifier
application number: M017
Re-Lieved 3 in 1 PatchMENTHOL, CAMPHOR, METHYL SALICYLATE PATCHTransfer Technologye9ab9a03-b9e3-7317-e053-2995a90a99502025-01-11WarningsExact identifier
application number: M017
ASTRAPHARM CHILLI BRANDCAPSAICINDersan Pharmaceutical Co., Ltdb4c2d4fd-7d5d-4156-ac27-e72ebc9671ec2025-01-10WarningsExact identifier
application number: M017
LABOFLEX Lidocaine Pain Relieving PatchLIDOCAINE 4%Laboflex, Inc.31995f31-c272-afdb-e063-6294a90af3f92025-01-10WarningsExact identifier
application number: M017
Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%Chain Drug Marketing Association Inc.2b48cb2f-e6bf-f9de-e063-6394a90a42d42025-01-09WarningsExact identifier
application number: M017
PAIN-XMENTHOLOL PHARMA TECH,LLCb22bb19a-14e5-3d32-e053-2a95a90ae5202025-01-09WarningsExact identifier
application number: M017
MUSCLE RUBMENTHOLOL PHARMA TECH,LLCb22c7999-52d5-25c3-e053-2a95a90a01f52025-01-09WarningsExact identifier
application number: M017
Biofreeze Professional Colorless Roll-OnMENTHOL, UNSPECIFIED FORMA-S Medication Solutionsce392c4f-cc43-484d-9c49-18fa25e4e5e92025-01-09WarningsExact identifier
application number: M017
NEW TEROCINMETHYL SALICYLATE, CAPSAICIN, AND MENTHOLA-S Medication Solutions43e5eb27-5541-4b7b-80de-55a79a4dce552025-01-09WarningsExact identifier
application number: M017
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMA-S Medication Solutionscbeac814-59d8-4c13-8e73-bca66f797f8d2025-01-09WarningsExact identifier
application number: M017
Bactine MaxLIDOCAINEWellSpring Pharmaceutical Corporationacd7ae37-7c42-4ec7-a2ef-42e7f628388d2025-01-08WarningsExact identifier
application number: M017
THERABLAST MAXIMUM RELIEFLIDOCAINE, MENTHOLReleaf Technologies LLC09809985-3a88-9bb7-e063-6394a90a2f5f2025-01-08WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198030nicotine 21 MG/Day 24HR Transdermal SystemPSN3a1abd26-c0aa-8a65-e063-6294a90ab66e1
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCD3a1abd26-c0aa-8a65-e063-6294a90ab66e1
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSY3a1abd26-c0aa-8a65-e063-6294a90ab66e1
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSY3a1abd26-c0aa-8a65-e063-6294a90ab66e1
198030nicotine 21 MG/Day 24HR Transdermal SystemSY3a1abd26-c0aa-8a65-e063-6294a90ab66e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85795-002-018579500020130 PATCH in 1 BOX (85795-002-01) 30 patch2025-07-17NoNoCurrent