FDA.reportPublic FDA data

Cepacol

Product NDC
17856-0732
11-digit product format
178560732
Labeler code
17856
Product ID
17856-0732_5d6b761e-c1c3-9d31-e063-6394a90ae8a7
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine and Menthol
Dosage form
LOZENGE
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
M
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-07-15
Substance
BENZOCAINE; MENTHOL
Active strength
15; 2.6 mg/1; mg/1
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct17856-0732IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage17856-073217856-0732-1IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Cepacol
Brand name suffix
Extra Strength Sore Throat honey lemon
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE15 mg/1
MENTHOL2.6 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-04-17Cēpacol ® Extra Strength* Sore Throat honey lemon
2024-04-17Cēpacol ® Extra Strength* Sore Throat honey lemon
2024-01-30Cēpacol ® Extra Strength* Sore Throat honey lemon
2024-01-30Cēpacol ® Extra Strength* Sore Throat honey lemon

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0732-1Cepacol Extra Strength Sore Throat honey lemon50 in 1 BOXLOZENGE507
17856-0732-2Cepacol Extra Strength Sore Throat honey lemon1 in 1 POUCHLOZENGE17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0732-1EA - Each17856-073234dca16d-b749-458e-a8b3-e810deab22dc12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0732CEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE [ATLANTIC BIOLOGICALS CORP.]6Current NDC, Legacy NDC, 2 package rows20240418_08160ced-e19b-443e-ab16-0d3e4ae8a8ab.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 6 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MAX relief juniorACETAMINOPHENATLANTIC BIOLOGICALS CORP.396903dc-ae2d-4bf4-b1fd-0017b84abef92024-02-28WarningsExact identifier
application number: M
MAX relief juniorACETAMINOPHENATLANTIC BIOLOGICALS CORP.44730cbd-5b98-49bd-b3b8-6fecb0ccd1532024-02-28WarningsExact identifier
application number: M
HYDROCORTISONEHYDROCORTISONE ACETATEHART Health779f945f-ab69-40de-8d86-ab76debc5c7c2024-02-16WarningsExact identifier
application number: M
First Aid and BurnBENZALKONIUM CHLORIDE, LIDOCAINEHART Healthf5746bba-9d7f-4691-b466-14985473bf142024-02-16WarningsExact identifier
application number: M
IBUPROFENIBUPROFENHART Health1c1374e1-890f-48ab-8f93-e84da9d5bf842024-01-25WarningsExact identifier
application number: M
Hand SanitizerANTISEPTIC GELHART Healthf07daf29-d0db-4cf8-8baf-d175c2b2ef502024-01-25WarningsExact identifier
application number: M
Hydrogen PeroxideHYDROGEN PEROXIDEHART Health0346a322-8f6e-405a-8d17-8bc6ce5105a32024-01-24WarningsExact identifier
application number: M
AlcoholISOPROPYL ALCOHOLNorMed441b915a-287f-4734-b4d9-730b3d95e04c2024-01-24WarningsExact identifier
application number: M
Sooth-a-StingBENZOCAINEHART Healthbd7229b6-813a-4149-bfe2-fe682f270ff42024-01-18WarningsExact identifier
application number: M
First AidBENZALKONIUM CHLORIDE, BENZOCAINEHART Healtha6d258ed-6d6d-42f0-9994-6c2c4c3d0f4a2024-01-18WarningsExact identifier
application number: M
TRIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEHART Healthd8f175f9-f526-4c73-a171-49309ca16cb02024-01-18Warnings, Adverse reactionsExact identifier
application number: M

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858664benzocaine 15 MG / menthol 2.6 MG Oral LozengePSN08160ced-e19b-443e-ab16-0d3e4ae8a8ab7
1235472Cepacol Sore Throat 15 MG / 2.6 MG Oral LozengePSN08160ced-e19b-443e-ab16-0d3e4ae8a8ab7
1235472benzocaine 15 MG / menthol 2.6 MG Oral Lozenge [Cepacol Sore Throat Pain Relief]SBD08160ced-e19b-443e-ab16-0d3e4ae8a8ab7
858664benzocaine 15 MG / menthol 2.6 MG Oral LozengeSCD08160ced-e19b-443e-ab16-0d3e4ae8a8ab7
1235472Cepacol Sore Throat Pain Relief 15/2.6 (benzocaine / menthol) Oral LozengeSY08160ced-e19b-443e-ab16-0d3e4ae8a8ab7
1235472Cepacol Sore Throat Pain Relief 15/2.6 Oral LozengeSY08160ced-e19b-443e-ab16-0d3e4ae8a8ab7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0732-11785607320150 POUCH in 1 BOX (17856-0732-1) / 1 LOZENGE in 1 POUCH50 pouch2024-04-170000-00-00NoNoCurrent
17856-0732-2178560732021 in 1 POUCHHistorical
17856-0732-71785607320747 POUCH in 1 BOX, UNIT-DOSE (17856-0732-7) / 1 LOZENGE in 1 POUCH47 pouch2026-10-08NoNoCurrent