FDA.reportPublic FDA data

NDC 68391-532-78 - berkley and jensen 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
68391-532
Requested NDC
68391-532-78
Package NDCs from labels
68391-532-76, 68391-532-78, 68391-532-82
Manufacturer
BJWC
Effective date
2015-07-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
berkley and jensen nicotine - BJWCBJWC2015-07-02HUMAN OTC DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RBERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC]4
NICOTINEACTIVE MOIETY6M3C89ZY6RBERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC]4
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9BERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC]4
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKBERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC]4
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZBERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC]4
GELATININACTIVE INGREDIENT2G86QN327LBERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC]4
MANNITOLINACTIVE INGREDIENT3OWL53L36ABERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC]4
POLACRILININACTIVE INGREDIENTRCZ785HI7SBERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC]4
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOBERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC]4
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TBERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC]4
SORBITOLINACTIVE INGREDIENT506T60A25RBERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC]4
TALCINACTIVE INGREDIENT7SEV7J4R1UBERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC]4
XYLITOLINACTIVE INGREDIENTVCQ006KQ1EBERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC]4

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 181 · 3,616 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NicotineNICOTINE POLACRILEXAmazon.com Services LLCda4c5203-76d7-454f-85bd-1717d95506bd2026-09-09WarningsExact identifier
unii: 6M3C89ZY6R
Childrens Stomach ReliefCALCIUM CARBONATEWal-Mart Stores Inc7471ec99-6c0b-40d8-a9cf-85240a0d471a2026-09-09WarningsExact identifier
unii: H0G9379FGK
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
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
COMPLETE ACID REDUCERFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDb023cd92-eabb-474b-9b5a-4b46cf48256b2026-09-08WarningsExact identifier
unii: H0G9379FGK
Walgreens Orange Antacid Soft ChewCALCIUM CARBONATEWalgreens5b01be31-5871-d4f5-e063-6294a90a671a2026-09-08WarningsExact identifier
unii: H0G9379FGK
Regular Strength Tropical FruitCALCIUM CARBONATERARITAN PHARMACEUTICALS INC38c6cece-71a0-40d8-bfc8-2f6467f9239b2026-09-05WarningsExact identifier
unii: H0G9379FGK
Extra Strength Antacid Assorted BerriesCALCIUM CARBONATERARITAN PHARMACEUTICALS INC07a50168-6b05-4c99-9969-7d7f0aa54f302026-09-05WarningsExact identifier
unii: H0G9379FGK
DRx CHOICE Antacid Calcium Regular StrengthCALCIUM CARBONATE 500MGRaritan Pharmaceuticals Inc0c579405-9397-4bf2-8441-e89011b19ec42026-09-05WarningsExact identifier
unii: H0G9379FGK
Tums Chewy Bites Wintermint and Vanilla CreamCALCIUM CARBONATEHaleon US Holdings LLC4f094feb-8de1-4ccb-e063-6294a90acec22026-09-04WarningsExact identifier
unii: H0G9379FGK
Nicotine MiniNICOTINE POLACRILEXHC Jones, Inc.d0d1a5ef-fd4c-4854-9453-68808cc0fab02026-09-03WarningsExact identifier
unii: 6M3C89ZY6R
DG health Ultra Strength Assorted Fruit AntacidCALCIUM CARBONATEDOLGENCORP, LLC98a0503c-add5-4453-9d9d-6f813866f4b32026-09-03WarningsExact identifier
unii: H0G9379FGK
NicotineNICOTINE POLACRILEXHC Jones, Inc.e07226e8-3be4-46e4-aa4f-c5d88db1ccfa2026-09-03WarningsExact identifier
unii: 6M3C89ZY6R
DG health Ultra Strength Assorted Berry AntacidCALCIUM CARBONATEDOLGENCORP, LLC99c7ab95-df12-4041-ae1a-398cc6f0085d2026-09-03WarningsExact identifier
unii: H0G9379FGK
DG HEALTH Ultra StrengthANTACID TABLETS (CALCIUM CARBONATE)DOLGENCORP, LLCe7be2ad1-c85c-4ac7-b6e7-641f979d0d6b2026-09-03WarningsExact identifier
unii: H0G9379FGK
DG HEALTH Liquid Antacid plus Anti GasCALCIUM CARBONATE, MAGNESIUM HYDROXIDE AND SIMETHICONEDOLGENCORP, LLC8ecb4418-e647-49b5-b418-1c63bb3e5a3c2026-09-03WarningsExact identifier
unii: H0G9379FGK
DG health Extra Strength AntacidCALCIUM CARBONATEDOLGENCORP, LLC4942747a-8b6c-422a-8150-9bd91c0a37782026-09-03WarningsExact identifier
unii: H0G9379FGK
nicotineNICOTINE POLACRILEXSixarp, LLC5a94092b-f80e-c656-e063-6294a90ab15a2026-09-03WarningsExact identifier
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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