FDA.reportPublic FDA data

Cepacol

Product NDC
17856-0732
Requested package NDC
17856-0732-7
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

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 1 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Simethicone 125MG Gas ReliefSIMETHICONE 125 MGOne2Zee Limited Liability Company0df348bf-5a07-4f36-ae70-ca2961a9ce7e2026-09-04WarningsExact identifier
application number: M
MG DermaSpray 70ETHYL ALCOHOLMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.153ed8ff-5632-4f21-84de-2b87ac2bef312026-08-04WarningsExact identifier
application number: M
The Original Mane n Tail Daily Control 2 in 1 Anti DandruffPYRITHIONE ZINCStraight Arrow Products Inc68ab55d6-b1a9-46c0-87f0-ec12ad3474bc2026-07-09WarningsExact identifier
application number: M
Stool Softener LaxativeDOCUSATE SODIUMATLANTIC BIOLOGICALS CORP.c1f588d0-4600-4b97-b2d3-2c08ac351e072026-06-30WarningsExact identifier
application number: M
Docusate SodiumDOCUSATE SODIUMPD-Rx Pharmaceuticals, Inc.66ca7a94-378b-4476-8060-d9c6f82f57fc2026-06-12WarningsExact identifier
application number: M
TRIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEHART Health3d17aba0-220f-42c4-9e26-5c44857847cd2026-05-20Warnings, Adverse reactionsExact identifier
application number: M
IT Cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Deep Deep Honey Deep Bronze Neutral Deep Deep Mocha Tan Cool Rich Cool Deep Cool Neutral RichHOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inc2a44a019-0cc0-439b-aaa5-37582ec5492e2026-05-14WarningsExact identifier
application number: M
THORACOLHONEY LEMON COUGH DROPSHART Healthfee9f594-c619-4d77-bb52-632078e0254e2026-04-16WarningsExact identifier
application number: M
First Aid and BurnBENZALKONIUM CHLORIDE, LIDOCAINEHART Health07d447f1-469c-4e34-b807-ede9a449e6ab2026-04-15WarningsExact identifier
application number: M
HYDROCORTISONEHYDROCORTISONE CREAMHART Healthc76fb030-cbb5-4773-aa52-d038cb41d0af2026-04-15WarningsExact identifier
application number: M
Hydrogen PeroxideHYDROGEN PEROXIDEAmazon.com Services LLC55b0d905-fcc0-40ba-a5dd-331a27a3a2092026-04-07Warnings, Adverse reactionsExact identifier
application number: M
Docusate SodiumDOCUSATE SODIUM 100MGPharbest Pharmaceuticals, Inc.025e03e0-e273-47ed-87f7-98e388abe0472026-03-05WarningsExact identifier
application number: M
TEENY TUMMY Gas Relief DropsSIMETHICONEALTANTIC BIOLOGICAS CORP.05eadb73-4468-4dae-a67b-133d893feed22026-02-13WarningsExact identifier
application number: M
Relief-PEACETAMINOPHEN, PHENYLEPHRINE, CHLORPHENIRAMINEHART Health9475fb51-931b-4a89-be6b-62e715d0883e2026-01-15WarningsExact identifier
application number: M
ASPIRINASPIRINHART Healtha1c73edf-861d-478b-9d3c-0eddcc6879cc2026-01-14WarningsExact identifier
application number: M
HISTAPRINDIPHENHYDRAMINENorMed38786a65-a12b-4479-b63c-b7c15410da042026-01-14WarningsExact identifier
application number: M
Blood ClottingBENZETHONIUM CHLORIDE AND LIDOCAINEHART Health21668731-8b8a-404f-80ab-962a0a9d5f632026-01-14WarningsExact identifier
application number: M
BandageBENZOCAINE AND BENZETHONIUM CHLORIDEHART Health6de57472-6dd0-43b6-8a82-fe459fa99ddb2026-01-14WarningsExact identifier
application number: M
Sooth-a-StingBENZOCAINE, ISOPROPYL ALCOHOLHART Healthc0e7d661-a9c9-4656-a516-57552848ebe82026-01-12WarningsExact identifier
application number: M
AlcoholISOPROPYL ALCOHOLHART Health8d01b10b-7916-420e-9d44-ebd3806fe3152026-01-12WarningsExact 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 startSampleExclude flagStatus
17856-0732-71785607320747 POUCH in 1 BOX, UNIT-DOSE (17856-0732-7) / 1 LOZENGE in 1 POUCH47 pouch2026-10-08NoNoCurrent