FDA.reportPublic FDA data

BACZOL EXPECTORANT

Product NDC
76864-209
11-digit product format
768640209
Labeler code
76864
Product ID
76864-209_2a4622c1-eef5-28e2-e063-6294a90abbfa
Type
HUMAN OTC DRUG
Nonproprietary name
GUAIFENESIN, PHENYLEPHRINE HCl
Dosage form
SYRUP
Route
ORAL
Labeler
Procaps S.A. de C.V.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-06-03
Substance
GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
200; 5 mg/5mL; mg/5mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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 EXPECTORANT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN200 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ, 04JA59TNSJ
Rxcui1370427

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
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76864-209-022023-08-28C16284748780-1f386c649-ca0e-0266-e053-dadaa90a7c1aBACZOL EXPECTORANT (Lex)
76864-209-022023-01-30C16284748780-1f386c649-ca0e-0266-e053-dadaa90a7c1aBACZOL EXPECTORANT (Lex)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76864-209-02BACZOL EXPECTORANT120 mL in 1 BOTTLE, PLASTICSYRUP1205
76864-209-02BACZOL EXPECTORANT1 in 1 CARTONSYRUP15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76864-209BACZOL EXPECTORANT (GUAIFENESIN, PHENYLEPHRINE HCL) SYRUP [PROCAPS S.A. DE C.V.]5Current NDC, Legacy NDC, 2 package rows20241228_8e928b79-2178-47ef-8427-6bb57f143261.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1370427guaiFENesin 200 MG / phenylephrine hydrochloride 5 MG in 5 mL Oral SolutionPSN8e928b79-2178-47ef-8427-6bb57f1432615
1370427guaifenesin 40 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCD8e928b79-2178-47ef-8427-6bb57f1432615
1370427guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 5 ML Oral SolutionSY8e928b79-2178-47ef-8427-6bb57f1432615

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76864-209-02768640209021 BOTTLE, PLASTIC in 1 CARTON (76864-209-02) / 120 mL in 1 BOTTLE, PLASTIC2021-06-030000-00-00NoNoCurrent