FDA.reportPublic FDA data

NDC 0135-0195-08 - NICODERM CQ

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
0135-0195
Requested NDC
0135-0195-08
Package NDCs from labels
0135-0195-02, 0135-0195-03, 0135-0195-08, 0135-0195-05
Manufacturer
Haleon US Holdings LLC
Effective date
2025-07-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
NICODERM CQ - Haleon US Holdings LLCHaleon US Holdings LLC2025-07-14HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0135-0195-022024-01-30C16284748780-11030e365-53bd-111a-e063-dadaa90a10e2Drug Facts
0135-0195-032024-01-30C16284748780-11030e365-53bd-111a-e063-dadaa90a10e2Drug Facts
0135-0195-052024-01-30C16284748780-11030e365-53bd-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0195-02NICODERMCQ24 h in 1 PATCHPATCH, EXTENDED RELEASE2414
0135-0195-02NICODERMCQ14 in 1 CARTONPATCH, EXTENDED RELEASE1414
0135-0195-03NICODERMCQ1 in 1 PACKAGEPATCH, EXTENDED RELEASE114
0135-0195-03NICODERMCQ21 in 1 CARTONPATCH, EXTENDED RELEASE2114
0135-0195-05NICODERMCQ14 in 1 CARTONPATCH, EXTENDED RELEASE1414
0135-0195-08NICODERMCQ24 h in 1 PATCHPATCH, EXTENDED RELEASE2414

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0195NICODERM CQ (NICOTINE) PATCH, EXTENDED RELEASE [HALEON US HOLDINGS LLC]13Current NDC, Legacy NDC, 6 package rows20250519_93b2d1b9-83c1-40b5-b6af-90c38c8d6cef.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0195-02EA - Each0135-01951051b6d9-5b9d-422f-b685-5af1e5bb2eae12012-07-24
0135-0195-03EA - Each0135-0195178d1ec3-2586-400d-a8a4-3246f132f4c612014-06-03
0135-0195-05EA - Each0135-01959c878f3a-cf66-48ca-9809-3447f30fa33312014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RNICODERM CQ (NICOTINE) PATCH, EXTENDED RELEASE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]5
NICOTINEACTIVE MOIETY6M3C89ZY6RNICODERM CQ (NICOTINE) PATCH, EXTENDED RELEASE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]5
ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE)INACTIVE INGREDIENTL5F16ZG4ZUNICODERM CQ (NICOTINE) PATCH, EXTENDED RELEASE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]5
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR7NICODERM CQ (NICOTINE) PATCH, EXTENDED RELEASE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]5

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 5 of 32 · 629 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Habitrol Nicotine Polacrilex Lozenge MintNICOTINE POLACRILEX LOZENGE 2 MGDr. Reddy's Laboratories Inc.836bae74-076b-3c92-dee9-22b8519b529d2026-07-09WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.003b863c-06b0-715d-ccc2-b7da4deac6212026-07-09WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXPublix Super Markets Inc8c296647-00a1-43d0-acd1-7c1e92f368832026-07-09WarningsExact identifier
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEXCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED0ef9e55d-83e0-4ba5-a905-8cddb0db00192026-07-09WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.b0fdb36d-4cf5-8a91-3da1-90e3587450f92026-07-09WarningsExact identifier
unii: 6M3C89ZY6R
Habitrol Lozenge Original FlavorNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.87714b79-05b3-f3c2-6505-5923e4f488712026-07-09WarningsExact identifier
unii: 6M3C89ZY6R
Habitrol Lozenge CherryNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.5a464242-7d63-141e-808e-c41676cf4b782026-07-09WarningsExact identifier
unii: 6M3C89ZY6R
nicotine coatedNICOTINE POLACRILEXPublix Super Markets Inc8cb5577b-48c0-47f8-8979-0ab54d7130452026-07-09WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.6b0342dd-120f-a16e-098a-dc45b14d3d3a2026-07-09WarningsExact identifier
unii: 6M3C89ZY6R
DG HEALTH NICOTINENICOTINE POLACRILEXDolgencorp Incb44f0525-abf6-461d-ae15-40d162021eaa2026-07-01WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine Transdermal System step 3NICOTINEAmerisourceBergen Drug Corporatione51d2c09-a20f-eb9b-e3e4-013f3e488ab32026-07-01WarningsExact identifier
rxcui: 198030
rxcui: 198031
rxcui: 198029
unii: 6M3C89ZY6R
Topcare NicotineNICOTINE POLACRILEXTopco Associates LLC03d9708a-923c-4fd3-ac3d-6ab4a4d8a8042026-06-30WarningsExact identifier
unii: 6M3C89ZY6R
topcare nicotineNICOTINE POLACRILEXTopco Associates LLCc3c52b83-fdbe-4999-b982-37c63462eb7c2026-06-30WarningsExact identifier
unii: 6M3C89ZY6R
Topcare NicotineNICOTINE POLACRILEXTopco Associates LLCf0f79275-c27a-4d35-a79a-53b0905c37612026-06-29WarningsExact identifier
unii: 6M3C89ZY6R
equate nicotineNICOTINE POLACRILEXWal-Mart Stores Inc768e3f3d-d867-4574-8a5d-07572e2e4a042026-06-29WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXH E B9bf10dfc-c6df-4cc9-ba79-2dcf874a29042026-06-26WarningsExact identifier
unii: 6M3C89ZY6R
Good Sense NicotineNICOTINE POLACRILEXL. Perrigo Companyb8cbb6a7-aeb4-48f3-a0ed-7ad8030217522026-06-26WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXH E Ba1f36614-539f-45db-aad4-1b300c60bf432026-06-26WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXH E B55defc7f-f91d-46eb-8558-2ab1b69ec6a12026-06-26WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXKroger Company35f45900-af2e-4b74-9772-8beb552364572026-06-26WarningsExact identifier
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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