Market Basket Cold Sore Treatment

Product NDC
53942-406
11-digit product format
539420406
Labeler code
53942
Product ID
53942-406_1d6c4554-9e73-4fca-8ae0-8e67e14eeefd
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Demoulas Supermarkets, Inc.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-07-19
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
1 mg/g
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct53942-406IInactivated by FDA2026-10-05
excluded packagepackage53942-40653942-406-01IInactivated by FDA2026-10-05

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53942-406-01IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53942-406-01IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53942-406-01IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53942-406-01IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53942-406-01IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53942-406-01IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53942-406-01IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53942-406-01IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53942-406-01IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53942-406-01IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53942-406-01IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53942-406-01IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53942-406-01IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53942-406-01IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53942-406-01IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage53942-406-01IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage53942-406-01IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage53942-406-01IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage53942-406-01IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53942-406-01IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53942-406-01IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage53942-406-01EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53942-406-012020-01-31C16284748780-19d75b9d0-8935-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53942-406-01Market Basket Cold Sore Treatment2 g in 1 TUBECREAM22
53942-406-01Market Basket Cold Sore Treatment1 in 1 PACKAGECREAM12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Benzalkonium ChlorideACTIVE INGREDIENTF5UM2KM3W7MARKET BASKET COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) CREAM [DEMOULAS SUPERMARKETS, INC.]2
BenzalkoniumACTIVE MOIETY7N6JUD5X6YMARKET BASKET COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) CREAM [DEMOULAS SUPERMARKETS, INC.]2
AlcoholINACTIVE INGREDIENT3K9958V90MMARKET BASKET COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) CREAM [DEMOULAS SUPERMARKETS, INC.]2
Aloe Vera LeafINACTIVE INGREDIENTZY81Z83H0XMARKET BASKET COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) CREAM [DEMOULAS SUPERMARKETS, INC.]2
Alpha-TocopherolINACTIVE INGREDIENTH4N855PNZ1MARKET BASKET COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) CREAM [DEMOULAS SUPERMARKETS, INC.]2
ArginineINACTIVE INGREDIENT94ZLA3W45FMARKET BASKET COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) CREAM [DEMOULAS SUPERMARKETS, INC.]2
ButylparabenINACTIVE INGREDIENT3QPI1U3FV8MARKET BASKET COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) CREAM [DEMOULAS SUPERMARKETS, INC.]2
Camphor (Synthetic)INACTIVE INGREDIENT5TJD82A1ETMARKET BASKET COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) CREAM [DEMOULAS SUPERMARKETS, INC.]2
CeresinINACTIVE INGREDIENTQ1LS2UJO3AMARKET BASKET COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) CREAM [DEMOULAS SUPERMARKETS, INC.]2
Cetearyl IsononanoateINACTIVE INGREDIENTP5O01U99NIMARKET BASKET COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) CREAM [DEMOULAS SUPERMARKETS, INC.]2
Corymbia Citriodora Leaf OilINACTIVE INGREDIENTM63U6N96EBMARKET BASKET COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) CREAM [DEMOULAS SUPERMARKETS, INC.]2
EthylparabenINACTIVE INGREDIENT14255EXE39MARKET BASKET COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) CREAM [DEMOULAS SUPERMARKETS, INC.]2
HexyldecanolINACTIVE INGREDIENT151Z7P1317MARKET BASKET COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) CREAM [DEMOULAS SUPERMARKETS, INC.]2
Hexyldecyl LaurateINACTIVE INGREDIENT0V595C1P6MMARKET BASKET COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) CREAM [DEMOULAS SUPERMARKETS, INC.]2
LevomentholINACTIVE INGREDIENTBZ1R15MTK7MARKET BASKET COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) CREAM [DEMOULAS SUPERMARKETS, INC.]2
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TMARKET BASKET COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) CREAM [DEMOULAS SUPERMARKETS, INC.]2
Poloxamer 407INACTIVE INGREDIENTTUF2IVW3M2MARKET BASKET COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) CREAM [DEMOULAS SUPERMARKETS, INC.]2
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHMARKET BASKET COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) CREAM [DEMOULAS SUPERMARKETS, INC.]2
Tea Tree OilINACTIVE INGREDIENTVIF565UC2GMARKET BASKET COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) CREAM [DEMOULAS SUPERMARKETS, INC.]2
ThymolINACTIVE INGREDIENT3J50XA376EMARKET BASKET COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) CREAM [DEMOULAS SUPERMARKETS, INC.]2
Zinc ChlorideINACTIVE INGREDIENT86Q357L16BMARKET BASKET COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) CREAM [DEMOULAS SUPERMARKETS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53942-406MARKET BASKET COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) CREAM [DEMOULAS SUPERMARKETS, INC.]2Legacy NDC, 2 package rows20110720_7f788cc9-ca81-45c6-8a11-6b90f34e6fc2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094748benzalkonium chloride 0.13 % Topical CreamPSN7f788cc9-ca81-45c6-8a11-6b90f34e6fc22
1094748benzalkonium chloride 1.3 MG/ML Topical CreamSCD7f788cc9-ca81-45c6-8a11-6b90f34e6fc22
1094748benzalkonium chloride 0.13 % Topical CreamSY7f788cc9-ca81-45c6-8a11-6b90f34e6fc22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
53942-406-01539420406012 g in 1 TUBE2 gHistorical