Mini Nicotine

Product NDC
69842-934
11-digit product format
698420934
Labeler code
69842
Product ID
69842-934_2ea5a873-a3ae-4099-95e1-d71f834fa61b
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA210711
Marketing category
ANDA
Marketing start
2020-06-30
Marketing end
2026-12-31
Substance
NICOTINE
Active strength
4 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210711-001NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2019-10-31
A210711-002NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2019-10-31

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A210711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2019-10-31caaa826d4ba7…
2026-08-18 06:07:402026-07A210711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2019-10-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2019-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2019-10-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2019-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2019-10-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2019-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2019-10-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2019-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2019-10-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2019-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2019-10-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2019-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2019-10-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2019-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2019-10-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2019-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2019-10-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2019-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2019-10-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2019-10-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A210711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2019-10-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2019-10-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2019-10-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2019-10-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2019-10-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2019-10-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2019-10-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2019-10-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2019-10-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2019-10-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2019-10-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2019-10-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2019-10-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2019-10-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2019-10-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2019-10-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A210711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2019-10-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2019-10-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2019-10-31bb7c543d1eb4…

Additional Listing Data#

Finished product
Yes
Brand name base
Mini Nicotine

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE4 mg/1

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
359818Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
89e2a6b9-e759-4c18-a04d-d6fc9f264575Available 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
69842-934-08Mini Nicotine4 in 1 BOXLOZENGE47
69842-934-08Mini Nicotine27 in 1 BOTTLE, PLASTICLOZENGE277
69842-934-89Mini Nicotine27 in 1 BOTTLE, PLASTICLOZENGE277
69842-934-89Mini Nicotine7 in 1 BOXLOZENGE77

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-934MINI NICOTINE (NICOTINE POLACRILEX) LOZENGE [CVS PHARMACY]4Current NDC, Legacy NDC, 4 package rows20221124_89e2a6b9-e759-4c18-a04d-d6fc9f264575.zip

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 1 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NicotineNICOTINE POLACRILEXP & L Development, LLC30e00817-75ff-43db-901c-c180e67309012026-08-06WarningsExact identifier
application applno (ANDA): 210711
application number: ANDA210711
Nicotine MiniNICOTINE POLACRILEXP & L Development, LLC3623455a-3f00-41d3-b17e-86a016da70472026-08-06WarningsExact identifier
application applno (ANDA): 210711
application number: ANDA210711
Nicotine MiniNICOTINE POLACRILEXHC Jones, Inc.80e9ee49-2b38-4b59-80a7-524021bf2b212026-04-07WarningsExact identifier
application applno (ANDA): 210711
application number: ANDA210711
NicotineNICOTINE POLACRILEXHC Jones, Inc.e07226e8-3be4-46e4-aa4f-c5d88db1ccfa2026-04-07WarningsExact identifier
application applno (ANDA): 210711
application number: ANDA210711
Nicotine MiniNICOTINE POLACRILEXWalgreens06455f66-da8e-4be5-9069-6840f93d6d772026-02-10WarningsExact identifier
application applno (ANDA): 210711
application number: ANDA210711
Nicotine MiniNICOTINE POLACRILEXWalgreens2af56565-7e28-4915-ad60-49570c98a2462026-02-04WarningsExact identifier
application applno (ANDA): 210711
application number: ANDA210711
Mini NicotineNICOTINE POLACRILEXCVS Pharmacy89e2a6b9-e759-4c18-a04d-d6fc9f2645752026-01-29WarningsExact identifier
application applno (ANDA): 210711
application number: ANDA210711
ndc (product): 69842-934
NicotineNICOTINE POLACRILEXWalgreens446c857f-2380-4019-9a82-9fb9ee060d082024-02-21WarningsExact identifier
application applno (ANDA): 210711
application number: ANDA210711
NicotineNICOTINE POLACRILEXWalgreens19bd0eb4-0cd6-4979-bef6-eedbd4d5de882024-02-20WarningsExact identifier
application applno (ANDA): 210711
application number: ANDA210711
Nicotine Sugar FreeNICOTINE POLACRILEXCVS Pharmacy8986c712-6399-450e-8178-01fef29ebc522023-12-22WarningsExact identifier
application applno (ANDA): 210711
application number: ANDA210711

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN89e2a6b9-e759-4c18-a04d-d6fc9f2645757
359818nicotine 4 MG Oral LozengeSCD89e2a6b9-e759-4c18-a04d-d6fc9f2645757
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY89e2a6b9-e759-4c18-a04d-d6fc9f2645757
359818nicotine 4 MG TrocheSY89e2a6b9-e759-4c18-a04d-d6fc9f2645757

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69842-934-08698420934084 BOTTLE, PLASTIC in 1 BOX (69842-934-08) / 27 LOZENGE in 1 BOTTLE, PLASTIC2020-06-302026-12-31NoNoCurrent
69842-934-89698420934897 BOTTLE, PLASTIC in 1 BOX (69842-934-89) / 27 LOZENGE in 1 BOTTLE, PLASTIC2020-06-302026-12-31NoNoCurrent