FDA.reportPublic FDA data

Cepacol

Product NDC
63824-732
11-digit product format
638240732
Labeler code
63824
Product ID
63824-732_51a73861-dad4-e880-e063-6294a90a9190
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine and Menthol
Dosage form
LOZENGE
Route
ORAL
Labeler
Reckitt Benckiser LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-07-15
Substance
BENZOCAINE; MENTHOL, UNSPECIFIED FORM
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

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
MENTHOL, UNSPECIFIED FORM2.6 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3RSY48JW5, L7T10EIP3A
Rxcui858664, 1235472

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63824-732-16CepacolExtra Strength Sore Throat honey lemon8 in 1 BLISTER PACKLOZENGE812
63824-732-16CepacolExtra Strength Sore Throat honey lemon2 in 1 CARTONLOZENGE212

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-732-16EA - Each63824-7327758e732-5bdc-4055-a3f5-57cf36bc3e5112014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BenzocaineACTIVE INGREDIENTU3RSY48JW5CEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]1
MentholACTIVE INGREDIENTL7T10EIP3ACEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]1
BenzocaineACTIVE MOIETYU3RSY48JW5CEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]1
MentholACTIVE MOIETYL7T10EIP3ACEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]1
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GCEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]1
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8CEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]1
isomaltINACTIVE INGREDIENTS870P55O2WCEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]1
maltitolINACTIVE INGREDIENTD65DG142WKCEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]1
sodium bicarbonateINACTIVE INGREDIENT8MDF5V39QOCEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]1
sucraloseINACTIVE INGREDIENT96K6UQ3ZD4CEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]1
waterINACTIVE INGREDIENT059QF0KO0RCEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63824-732CEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE [RB HEALTH (US) LLC]9Current NDC, Legacy NDC, 2 package rows20250330_d771095b-7de3-48f3-a125-8bc76e7d1778.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858664benzocaine 15 MG / menthol 2.6 MG Oral LozengePSNd771095b-7de3-48f3-a125-8bc76e7d177812
1235472Cepacol Sore Throat 15 MG / 2.6 MG Oral LozengePSNd771095b-7de3-48f3-a125-8bc76e7d177812
1235472benzocaine 15 MG / menthol 2.6 MG Oral Lozenge [Cepacol Sore Throat Pain Relief]SBDd771095b-7de3-48f3-a125-8bc76e7d177812
858664benzocaine 15 MG / menthol 2.6 MG Oral LozengeSCDd771095b-7de3-48f3-a125-8bc76e7d177812
1235472Cepacol Sore Throat Pain Relief 15/2.6 (benzocaine / menthol) Oral LozengeSYd771095b-7de3-48f3-a125-8bc76e7d177812
1235472Cepacol Sore Throat Pain Relief 15/2.6 Oral LozengeSYd771095b-7de3-48f3-a125-8bc76e7d177812
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
63824-732-16638240732162 BLISTER PACK in 1 CARTON (63824-732-16) / 8 LOZENGE in 1 BLISTER PACK2 blister pack2013-07-150000-00-00NoNoCurrent