FDA.reportPublic FDA data

Father Johns Cough Medicine Plus

Product NDC
45728-445
11-digit product format
457280445
Labeler code
45728
Product ID
45728-445_0ccb5970-3697-9097-e063-6294a90aa811
Type
HUMAN OTC DRUG
Nonproprietary name
Nasal Decongestant
Dosage form
LIQUID
Route
ORAL
Labeler
Oakhurst Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-06-17
Substance
DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE
Active strength
10; 10; 4 mg/30mL; mg/30mL; mg/30mL
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
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
Father Johns Cough Medicine Plus
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/30mL
PHENYLEPHRINE HYDROCHLORIDE10 mg/30mL
CHLORPHENIRAMINE MALEATE4 mg/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
04JA59TNSJInternal UNII lookup
V1Q0O9OJ9ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2167740Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8b8aab0f-251b-6bd8-e053-2995a90ad748Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45728-445-94Father Johns Cough Medicine Plus1 in 1 CARTONLIQUID16
45728-445-94Father Johns Cough Medicine Plus118 mL in 1 CONTAINERLIQUID1186

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45728-445FATHER JOHNS COUGH MEDICINE PLUS (NASAL DECONGESTANT) LIQUID [OAKHURST COMPANY]6Current NDC, Legacy NDC, 2 package rows20231219_8b8aab0f-251b-6bd8-e053-2995a90ad748.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 65 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy Relief Dye FreeDIPHENHYDRAMINE HYDROCHLORIDE 25MGWalgreens36ba3ff2-1965-aa56-e063-6294a90afe172025-12-31WarningsExact identifier
application number: M012
Sinus Congestion and Pain SevereACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCLWal-Mart Stores Incf51d1d52-39c2-4259-8b30-f9ac21edb2652025-12-31WarningsExact identifier
application number: M012
DurahistDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCLPoly Pharmaceuticals, Inc.33d71863-5cac-669f-e063-6394a90a6f212025-12-30WarningsExact identifier
application number: M012
Chest Congestion ReliefGUAIFENESINRUGBY LABORATORIES51b088bc-b44f-44b9-a08e-133509a35a2c2025-12-30WarningsExact identifier
application number: M012
Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINRUGBY LABORATORIES60c9e493-f58c-45d6-bade-c952975124032025-12-30WarningsExact identifier
application number: M012
BIO-RYTUSSCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEAdvanced Generic Corporatione48e46e3-d3fa-4b25-8b07-bbecc4f0b64b2025-12-30WarningsExact identifier
application number: M012
AltitussDEXTROMETHORPHAN HBR, GUAIFENESINAlternative Pharmacal Corporatione4ac96f5-2a3a-42a8-8db5-80de4dcdbd442025-12-30WarningsExact identifier
application number: M012
BiocofDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HCLAdvanced Generic Corporation6ae6a0cb-b4fc-4e7d-aefc-6a52ca1ae3d62025-12-30WarningsExact identifier
application number: M012
Altipres PediatricDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLAdvanced Generic Corporation2a336896-a2f8-2a0c-e063-6294a90ae03a2025-12-30WarningsExact identifier
application number: M012
AltipresDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLAlternative Pharmacal Corporationc5a43107-3eb8-46bb-87bd-20deafe28c3f2025-12-30WarningsExact identifier
application number: M012
Mucus Relief DMDEXTROMETHORPHAN HBR, GUAIFENESINChain Drug Marketing Association, Inc.d02f32c1-716e-4753-abba-ff97c4dc9e222025-12-30WarningsExact identifier
application number: M012
NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLKROGERa690f5c5-ff41-4072-e053-2995a90a8e552025-12-29WarningsExact identifier
application number: M012
NinjacofCHLOPHEDIANOL HCL AND PYRILAMINE MALEATECenturion Labs, LLCe2bca40f-9c27-ec8b-2ff0-ef9847ba20372025-12-29WarningsExact identifier
application number: M012
QUALITY CHOICECOUGH DROPS CHERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.23079194-b5e7-d5e6-e063-6394a90a4d8c2025-12-29WarningsExact identifier
application number: M012
QUALITY CHOICECOUGH DROPS HONEY LEMONXiamen Kang Zhongyuan Biotechnology Co., Ltd.2307db15-592b-138a-e063-6394a90a23a52025-12-29WarningsExact identifier
application number: M012
QUALITY CHOICE Cough Drops Vanilla HoneyCOUGH DROPS VANILLA HONEYXiamen Kang Zhongyuan Biotechnology Co., Ltd.23087ee3-26a0-e2b8-e063-6394a90abef42025-12-29WarningsExact identifier
application number: M012
QUALITY CHOICE Cough Drops Black Cherry SUGAR FREECOUGH DROPS BLACK CHERRY SUGAR FREEXiamen Kang Zhongyuan Biotechnology Co., Ltd.230883da-de48-68e9-e063-6394a90a927c2025-12-29WarningsExact identifier
application number: M012
QUALITY CHOICECOUGH DROPS VITAMIN CXiamen Kang Zhongyuan Biotechnology Co., Ltd.23086723-5718-6d02-e063-6394a90a03d22025-12-29WarningsExact identifier
application number: M012
QUALITY CHOICE Cough Drops Creamy StrawberryCOUGH DROPS CREAMY STRAWBERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.23085717-b2ee-175c-e063-6394a90a7f542025-12-29WarningsExact identifier
application number: M012
QUALITY CHOICECOUGH DROPS MENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.2307bbe9-7c8f-4eff-e063-6394a90af4c32025-12-29WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2167740chlorpheniramine maleate 4 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 10 MG in 30 mL Oral SolutionPSN8b8aab0f-251b-6bd8-e053-2995a90ad7486
2167740chlorpheniramine maleate 0.133 MG/ML / dextromethorphan hydrobromide 0.333 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCD8b8aab0f-251b-6bd8-e053-2995a90ad7486
2167740chlorpheniramine maleate 0.133 MG/ML / dextromethorphan HBr 0.333 MG/ML / phenylephrine HCl 0.333 MG/ML Oral SolutionSY8b8aab0f-251b-6bd8-e053-2995a90ad7486

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45728-445-94457280445941 CONTAINER in 1 CARTON (45728-445-94) / 118 mL in 1 CONTAINER1 container2019-06-170000-00-00NoNoCurrent