FDA.reportPublic FDA data

Cepacol

Product NDC
63824-744
Requested package NDC
63824-744-16
11-digit product format
638240744
Labeler code
63824
Product ID
63824-744_51b5d087-def6-54b3-e063-6294a90ac9ad
Type
HUMAN OTC DRUG
Nonproprietary name
BENZOCAINE and DEXTROMETHORPHAN HYDROBROMIDE
Dosage form
LOZENGE
Route
ORAL
Labeler
Reckitt Benckiser LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-05-05
Substance
BENZOCAINE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
7.5; 5 mg/1; mg/1
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Standardized Chemical Allergen [EPC], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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 and Cough
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE7.5 mg/1
BENZOCAINE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
U3RSY48JW5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1039251Internal RxNorm lookup
1039255Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c0cc32db-90f0-4106-8538-89821083ece1Available on FDA.report

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
63824-744-16CepacolExtra Strength Sore Throat and Cough8 in 1 BLISTER PACKLOZENGE814
63824-744-16CepacolExtra Strength Sore Throat and Cough2 in 1 CARTONLOZENGE214
63824-744-36CepacolExtra Strength Sore Throat and Cough3 in 1 CARTONLOZENGE314
63824-744-36CepacolExtra Strength Sore Throat and Cough12 in 1 BLISTER PACKLOZENGE1214
63824-744-94CepacolExtra Strength Sore Throat and Cough4 in 1 BLISTER PACKLOZENGE414
63824-744-94CepacolExtra Strength Sore Throat and Cough1 in 1 CARTONLOZENGE114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-744-16EA - Each63824-7447cd08d15-6f23-4040-a102-e5213cd3402512019-03-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5CEPACOL EXTRA STRENGTH SORE THROAT AND COUGH (BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RECKITT BENCKISER LLC]2
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCEPACOL EXTRA STRENGTH SORE THROAT AND COUGH (BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RECKITT BENCKISER LLC]2
BENZOCAINEACTIVE MOIETYU3RSY48JW5CEPACOL EXTRA STRENGTH SORE THROAT AND COUGH (BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RECKITT BENCKISER LLC]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCEPACOL EXTRA STRENGTH SORE THROAT AND COUGH (BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RECKITT BENCKISER LLC]2
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDCEPACOL EXTRA STRENGTH SORE THROAT AND COUGH (BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RECKITT BENCKISER LLC]2
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOACEPACOL EXTRA STRENGTH SORE THROAT AND COUGH (BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RECKITT BENCKISER LLC]2
isomaltINACTIVE INGREDIENTS870P55O2WCEPACOL EXTRA STRENGTH SORE THROAT AND COUGH (BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RECKITT BENCKISER LLC]2
maltitolINACTIVE INGREDIENTD65DG142WKCEPACOL EXTRA STRENGTH SORE THROAT AND COUGH (BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RECKITT BENCKISER LLC]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CEPACOL EXTRA STRENGTH SORE THROAT AND COUGH (BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RECKITT BENCKISER LLC]2
sodium bicarbonateINACTIVE INGREDIENT8MDF5V39QOCEPACOL EXTRA STRENGTH SORE THROAT AND COUGH (BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RECKITT BENCKISER LLC]2
sucraloseINACTIVE INGREDIENT96K6UQ3ZD4CEPACOL EXTRA STRENGTH SORE THROAT AND COUGH (BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RECKITT BENCKISER LLC]2
waterINACTIVE INGREDIENT059QF0KO0RCEPACOL EXTRA STRENGTH SORE THROAT AND COUGH (BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RECKITT BENCKISER LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63824-744CEPACOL EXTRA STRENGTH SORE THROAT AND COUGH (BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RB HEALTH (US) LLC]10Current NDC, Legacy NDC, 6 package rows20250323_c0cc32db-90f0-4106-8538-89821083ece1.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 194 · 3,880 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar Services Incce590997-3cae-4f22-ac39-2b14d39494bc2026-07-30WarningsExact identifier
application number: M012
Robitussin Direct CoughDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC70c9556b-063a-4fb3-96f6-1d4ffa495ed42026-07-30WarningsExact identifier
application number: M012
Major Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.a302e341-1c00-4c3d-b71f-c4c0b307aa672026-07-29WarningsExact identifier
application number: M012
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreens4c737cd6-fe56-4cef-887c-cd6cf83b254c2026-07-29WarningsExact identifier
application number: M012
ROBITUSSIN LONG-ACTING COUGHGELSDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC472c5c1f-eb5a-444b-a17e-f0d71007fb152026-07-29WarningsExact identifier
application number: M012
DAYTIME COLD AND FLU NITETIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEMeijer Distribution Inc3a33c6ce-aada-4099-8c61-49c86c0fc1a82026-07-29WarningsExact identifier
application number: M012
Tussin DM Max NighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWal-Mart Stores Inc668c92ce-6c1f-4ab3-b0dd-822b0768cb5e2026-07-29WarningsExact identifier
application number: M012
BenadrylDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC702f9786-7ce9-43e4-921d-e1db096121272026-07-28WarningsExact identifier
application number: M012
LoHist-DCHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCLLarken Laboratories, Inc.efaa354e-c25c-405b-9d30-001c2796978c2026-07-28WarningsExact identifier
application number: M012
NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd1115a55-35cd-4f20-8872-f42983a5ebcd2026-07-28WarningsExact identifier
application number: M012
TUSSINDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINSafewaya5e2bda4-2da6-4c20-855d-2888dadf0c3a2026-07-28WarningsExact identifier
application number: M012
DM MaximumDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDf6029b04-e681-40fc-be4f-14091b76dd4e2026-07-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLCVS PHARMACYe958eef1-8aae-4365-ac64-95a9e8e7e0f22026-07-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLDOLGENCORP INC38400854-27fa-e291-e063-6294a90a5c4e2026-07-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLBetter Living Brands, LLC65802aa7-64e7-4435-ad6b-65895fba17ce2026-07-27WarningsExact identifier
application number: M012
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCLWalgreen Company0a48f650-ad2a-4105-9ff4-2bc4d94b46d32026-07-27WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company84202ebe-97b6-4be2-bb09-7f2729303f962026-07-27WarningsExact identifier
application number: M012
Daytime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation8d41defe-8120-4cbb-b42e-c805cc5a794b2026-07-24WarningsExact identifier
application number: M012
Childrens Benadryl ALLERGYDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLCfc9181b9-c92d-493e-8d7c-4a4239c6c0922026-07-24WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDEProdose, Inc.3afc88c7-388a-dbd9-e063-6294a90a4faf2026-07-24WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039255Cepacol Sore Throat Plus Cough 7.5 MG / 5 MG Oral LozengePSNc0cc32db-90f0-4106-8538-89821083ece114
1039251dextromethorphan HBr 5 MG / benzocaine 7.5 MG Oral LozengePSNc0cc32db-90f0-4106-8538-89821083ece114
1039255benzocaine 7.5 MG / dextromethorphan hydrobromide 5 MG Oral Lozenge [Cepacol Sore Throat Plus Cough]SBDc0cc32db-90f0-4106-8538-89821083ece114
1039251benzocaine 7.5 MG / dextromethorphan hydrobromide 5 MG Oral LozengeSCDc0cc32db-90f0-4106-8538-89821083ece114
1039255Cepacol Sore Throat Plus Cough (benzocaine 7.5 MG / dextromethorphan hydrobromide 5 MG) Oral LozengeSYc0cc32db-90f0-4106-8538-89821083ece114

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63824-744-16638240744162 BLISTER PACK in 1 CARTON (63824-744-16) / 8 LOZENGE in 1 BLISTER PACK2 blister pack2014-05-050000-00-00NoNoCurrent