Sunmark Nicotine

Product NDC
49348-852
11-digit product format
493480852
Labeler code
49348
Product ID
49348-852_4c099d2c-14f8-4865-9730-cc5acfe37fce
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
ANDA077007
Marketing category
ANDA
Marketing start
2008-05-07
Marketing end
0000-00-00
Substance
NICOTINE
Active strength
2 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49348-852DDiscontinued by firm2026-08-03
excluded packagepackage49348-85249348-852-16DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49348-852-16d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49348-852-16f5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A077007-001NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2006-01-31
A077007-002NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2006-01-31

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077007-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2006-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077007-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2006-01-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077007-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2006-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077007-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2006-01-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077007-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2006-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077007-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2006-01-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077007-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2006-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077007-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2006-01-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077007-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2006-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077007-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2006-01-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077007-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2006-01-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077007-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2006-01-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077007-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2006-01-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077007-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2006-01-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077007-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2006-01-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077007-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2006-01-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077007-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2006-01-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077007-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2006-01-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077007-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2006-01-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A077007-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2006-01-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077007-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2006-01-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077007-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2006-01-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077007-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2006-01-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077007-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2006-01-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077007-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2006-01-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077007-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2006-01-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077007-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2006-01-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077007-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2006-01-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077007-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2006-01-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077007-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2006-01-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077007-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2006-01-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077007-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2006-01-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077007-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2006-01-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077007-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2006-01-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077007-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2006-01-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077007-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2006-01-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077007-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2006-01-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077007-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2006-01-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077007-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2006-01-31782e0a99824c…
2021-12-28 21:50 UTC2021-12A077007-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2006-01-31782e0a99824c…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-852-16EA - Each49348-852a06d9306-9271-4d2f-b516-73f92d7afef312012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-852SUNMARK NICOTINE (NICOTINE POLACRILEX) LOZENGE [STRATEGIC SOURCING SERVICES LLC]8Legacy NDC20241225_a0514034-11cc-418e-87af-900877817c48.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 4 · 75 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
nicotineNICOTINE POLACRILEXPublix Super Markets Inc00b40bb3-3785-4a53-804e-633795e87f712026-07-20WarningsExact identifier
application applno (ANDA): 077007
application number: ANDA077007
EQUATE NICOTINENICOTINE POLACRILEXWALMART INC.b6379f86-1528-465d-9527-bd2fead0068f2026-07-15WarningsExact identifier
application applno (ANDA): 077007
application number: ANDA077007
Good Sense NicotineNICOTINE POLACRILEXL. Perrigo Company5c89061b-1452-4962-9f25-212f2ae8e41e2026-07-13WarningsExact identifier
application applno (ANDA): 077007
application number: ANDA077007
nicotine coatedNICOTINE POLACRILEXPublix Super Markets Inca0113a1d-3691-4f18-9950-ae6d8d7d19ea2026-07-10WarningsExact identifier
application applno (ANDA): 077007
application number: ANDA077007
NICOTINENICOTINE POLACRILEXCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED0ef9e55d-83e0-4ba5-a905-8cddb0db00192026-07-09WarningsExact identifier
application applno (ANDA): 077007
application number: ANDA077007
nicotine coatedNICOTINE POLACRILEXPublix Super Markets Inc8cb5577b-48c0-47f8-8979-0ab54d7130452026-07-09WarningsExact identifier
application applno (ANDA): 077007
application number: ANDA077007
NicotineNICOTINE POLACRILEXKroger Company35f45900-af2e-4b74-9772-8beb552364572026-06-26WarningsExact identifier
application applno (ANDA): 077007
application number: ANDA077007
NicotineNICOTINE POLACRILEXKroger Company0ef57432-471d-4c7a-b8be-0f898f01d1972026-06-26WarningsExact identifier
application applno (ANDA): 077007
application number: ANDA077007
berkley and jensen nicotineNICOTINE POLACRILEXBJWC3a408d89-974f-4a20-aee9-fb1fe0a7ef3e2026-06-25WarningsExact identifier
application applno (ANDA): 077007
application number: ANDA077007
NICOTINENICOTINE POLACRILEXPublix Super Markets Incd043920e-d795-4eff-aadd-4c81b01503ea2026-06-22WarningsExact identifier
application applno (ANDA): 077007
application number: ANDA077007
NICOTINENICOTINE POLACRILEXH E B9c0122e4-7b5b-40c6-a981-1f7853bf3ce72026-06-18WarningsExact identifier
application applno (ANDA): 077007
application number: ANDA077007
NicotineNICOTINE POLACRILEXRite Aid Corporation8b24aefd-1881-4126-9188-29896a17a06d2026-06-03WarningsExact identifier
application applno (ANDA): 077007
application number: ANDA077007
NicotineNICOTINE POLACRILEXHyVee Inc7e391e5d-a715-42ae-8c4d-0a7d1a8599892026-06-03WarningsExact identifier
application applno (ANDA): 077007
application number: ANDA077007
nicotineNICOTINE POLACRILEXCVS Pharmacy4bc94e0b-189f-47b0-826c-2ccf6c4a0e3a2026-06-01WarningsExact identifier
application applno (ANDA): 077007
application number: ANDA077007
NicotineNICOTINE POLACRILEXRite Aid Corporation9e411b49-c8c4-43f8-a402-5ca2d96db1312026-05-27WarningsExact identifier
application applno (ANDA): 077007
application number: ANDA077007
Good Sense NicotineNICOTINE POLACRILEXL. Perrigo Company0ac7f87a-63f4-4d74-ba5b-d1444803b1002026-05-11WarningsExact identifier
application applno (ANDA): 077007
application number: ANDA077007
NicotineNICOTINE POLACRILEXWalgreen Company77688e56-4293-4f37-9f48-fe09267ff6192026-05-07WarningsExact identifier
application applno (ANDA): 077007
application number: ANDA077007
equate nicotineNICOTINE POLACRILEXWal-Mart Stores Inc53387dd6-28c0-412d-bc74-4d323c8d5e112026-04-16WarningsExact identifier
application applno (ANDA): 077007
application number: ANDA077007
NICOTINENICOTINE POLACRILEXHyVee Inc6415ebf4-5b6f-4811-997d-27c76893bc042026-03-19WarningsExact identifier
application applno (ANDA): 077007
application number: ANDA077007
nicotine lozengeNICOTINE POLACRILEXH E Bdb78d030-7abf-494f-94ca-4a385f519faf2026-02-27WarningsExact identifier
application applno (ANDA): 077007
application number: ANDA077007

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49348-852-16493480852163 CONTAINER in 1 CARTON (49348-852-16) > 24 LOZENGE in 1 CONTAINER3 container2009-10-270000-00-00NoNoCurrent