BACZOL COLD MEDICINE

Product NDC
76864-208
11-digit product format
768640208
Labeler code
76864
Product ID
76864-208_2a45dc86-5be1-b1a4-e063-6394a90ae5df
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, DEXTROMETHORPHAN HBr, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCl
Dosage form
SYRUP
Route
ORAL
Labeler
Procaps S.A. de C.V.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-05-25
Substance
ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
250; 4; 10; 10 mg/5mL; mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BACZOL COLD MEDICINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN250 mg/5mL
CHLORPHENIRAMINE MALEATE4 mg/5mL
DEXTROMETHORPHAN HYDROBROMIDE10 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE10 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, V1Q0O9OJ9Z, 9D2RTI9KYH, 04JA59TNSJ
Rxcui1370440

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76864-208-012023-08-28C16284748780-1f386c649-e5ac-0266-e053-dadaa90a7c1aBACZOL COLD (Lex)
76864-208-012023-01-30C16284748780-1f386c649-e5ac-0266-e053-dadaa90a7c1aBACZOL COLD (Lex)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76864-208-01BACZOL COLD MEDICINE120 mL in 1 BOTTLE, PLASTICSYRUP1206
76864-208-01BACZOL COLD MEDICINE1 in 1 CARTONSYRUP16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76864-208BACZOL COLD MEDICINE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) SYRUP [PROCAPS S.A. DE C.V.]6Current NDC, Legacy NDC, 2 package rows20241228_9d07b895-27ff-48b4-a597-29782a67a201.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1370440acetaminophen 250 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 10 MG in 5 mL Oral SolutionPSN9d07b895-27ff-48b4-a597-29782a67a2016
1370440acetaminophen 50 MG/ML / chlorpheniramine maleate 0.8 MG/ML / dextromethorphan hydrobromide 2 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral SolutionSCD9d07b895-27ff-48b4-a597-29782a67a2016
1370440acetaminophen 250 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 10 per 5 ML Oral SolutionSY9d07b895-27ff-48b4-a597-29782a67a2016
1370440APAP 50 MG/ML / Chlorpheniramine Maleate 0.8 MG/ML / Dextromethorphan Hydrobromide 2 MG/ML / Phenylephrine Hydrochloride 2 MG/ML Oral SolutionSY9d07b895-27ff-48b4-a597-29782a67a2016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76864-208-01768640208011 BOTTLE, PLASTIC in 1 CARTON (76864-208-01) / 120 mL in 1 BOTTLE, PLASTIC2020-05-250000-00-00NoNoCurrent