FDA.reportPublic FDA data

NDC 0536-5894-33 - Nicotine

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
0536-5894
Requested NDC
0536-5894-33
Package NDCs from labels
0536-5894-53, 0536-5894-88, 0536-5894-33
Manufacturer
A-S Medication Solutions
Effective date
2025-05-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nicotine - A-S Medication SolutionsA-S Medication Solutions2025-05-30HUMAN OTC DRUG LABEL
Nicotine Transdermal SystemRugby Laboratories | Aveva Drug Delivery Systems, Inc.2024-06-05HUMAN OTC DRUG LABEL
Nicotine - Rugby LaboratoriesRugby Laboratories2014-08-27HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0536-5894-532024-01-29Nicotine Transdermal System
0536-5894-882024-01-29Nicotine Transdermal System
0536-5894-532023-01-30Nicotine Transdermal System
0536-5894-882023-01-30Nicotine Transdermal System
0536-5894-532021-02-23Nicotine Transdermal System
0536-5894-882021-02-23Nicotine Transdermal System
0536-5894-532021-01-29Nicotine Transdermal System
0536-5894-882021-01-29Nicotine Transdermal System

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-5894-53Nicotine1 h in 1 POUCHPATCH116
0536-5894-53Nicotine7 in 1 CARTONPATCH716
0536-5894-88Nicotine14 in 1 CARTONPATCH1416
0536-5894-88Nicotine1 h in 1 POUCHPATCH116

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-5894NICOTINE PATCH [RUGBY LABORATORIES]16Current NDC, Legacy NDC, 4 package rows20240625_2dd4cbda-5c46-4655-b69d-21b7d2e912cf.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-5894-33EA - Each0536-58947e92b8cf-f237-4f17-bbee-ea27683f305a12015-06-09
0536-5894-53EA - Each0536-58941fbb63df-3878-4d0d-9205-0b5b80798c8312017-06-15
0536-5894-88EA - Each0536-58947d0d551f-b61e-4fb3-923d-fec55a9281d812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RNICOTINE PATCH [RUGBY LABORATORIES]9
NICOTINEACTIVE INGREDIENT6M3C89ZY6RNICOTINE PATCH [RUGBY LABORATORIES]9
NICOTINEACTIVE MOIETY6M3C89ZY6RNICOTINE PATCH [RUGBY LABORATORIES]9
NICOTINEACTIVE MOIETY6M3C89ZY6RNICOTINE PATCH [RUGBY LABORATORIES]9
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1ONICOTINE PATCH [RUGBY LABORATORIES]9
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1ONICOTINE PATCH [RUGBY LABORATORIES]9

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 1 of 64 · 1,263 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic MultipurposeDIMETHICONEL'Oreal USA Products Inc805cd262-2689-4818-8fed-ddefacbdde232026-09-10WarningsExact identifier
unii: 92RU3N3Y1O
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic MultipurposeDIMETHICONECosmetique Active Productiond19f482c-bec7-45aa-b22f-fe91a3dc717d2026-09-10WarningsExact identifier
unii: 92RU3N3Y1O
NicotineNICOTINE POLACRILEXAmazon.com Services LLCda4c5203-76d7-454f-85bd-1717d95506bd2026-09-09WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXRite Aid Corporation09bc9f57-fed2-42d9-b4f2-2b71b8baa0a92026-09-09WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXRite Aid Corporationc94d46b1-f526-4af0-8f7c-8261b9ed68412026-09-09WarningsExact identifier
unii: 6M3C89ZY6R
Good Sense NicotineNICOTINE POLACRILEXL. Perrigo Companyae802de5-8e1b-439f-ab81-db4bd7241c912026-09-09WarningsExact identifier
unii: 6M3C89ZY6R
MedlineDIMETHICONEMedline Industries, LP5afb3595-f014-153e-e063-6294a90ad34b2026-09-08WarningsExact identifier
unii: 92RU3N3Y1O
MedlineDIMETHICONEMedline Industries, LP5afb59b4-491c-45bb-e063-6294a90a0ae62026-09-08WarningsExact identifier
unii: 92RU3N3Y1O
Gas Relief Mint FlavorSIMETHICONERaritan Pharmaceuticals Inc329388cb-3ca1-4ecb-8b50-b1f9e00525592026-09-08WarningsExact identifier
unii: 92RU3N3Y1O
Simethicone 125MG Gas ReliefSIMETHICONE 125 MGOne2Zee Limited Liability Company0df348bf-5a07-4f36-ae70-ca2961a9ce7e2026-09-04WarningsExact identifier
unii: 92RU3N3Y1O
anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONERite Aid Corporation8e954f86-bc15-45e2-9274-ca5d8a7c96872026-09-04WarningsExact identifier
unii: 92RU3N3Y1O
Nicotine MiniNICOTINE POLACRILEXHC Jones, Inc.d0d1a5ef-fd4c-4854-9453-68808cc0fab02026-09-03WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXHC Jones, Inc.e07226e8-3be4-46e4-aa4f-c5d88db1ccfa2026-09-03WarningsExact identifier
unii: 6M3C89ZY6R
Infants Gas Relief DropsSIMETHICONEDOLGENCORP INC6b132ac0-e8eb-4199-85ad-5976558ee9c82026-09-03WarningsExact identifier
unii: 92RU3N3Y1O
DG HEALTH Liquid Antacid plus Anti GasCALCIUM CARBONATE, MAGNESIUM HYDROXIDE AND SIMETHICONEDOLGENCORP, LLC8ecb4418-e647-49b5-b418-1c63bb3e5a3c2026-09-03WarningsExact identifier
unii: 92RU3N3Y1O
nicotineNICOTINE POLACRILEXSixarp, LLC5a94092b-f80e-c656-e063-6294a90ab15a2026-09-03WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine MiniNICOTINE POLACRILEXHC Jones, Inc.80e9ee49-2b38-4b59-80a7-524021bf2b212026-09-03WarningsExact identifier
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEXAmazon.com Services LLCec341a77-5b62-4980-8d31-27c12ae925612026-09-03WarningsExact identifier
unii: 6M3C89ZY6R
Mini NicotineNICOTINE POLACRILEXHC Jones, Inc.ff9e34ff-5086-4e1b-9220-27ac2ac1069c2026-09-03WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine Polacrilex Original FlavorNICOTINE POLACRILEXPublix Supermarkets, Inc.540c88bd-70dc-416a-8d8e-0a33b2b295632026-09-02WarningsExact identifier
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.