FDA.reportPublic FDA data

COLTALIN-ND

Product NDC
51467-013
11-digit product format
514670013
Labeler code
51467
Product ID
51467-013_5bb2cbef-8d82-e8c7-e063-6394a90a4bb2
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Phenylephrine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
FORTUNE PHARMACAL COMPANY LIMITED
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-07-01
Marketing end
2029-06-30
Substance
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 5 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
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
COLTALIN-ND

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

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
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51467-013-01COLTALIN-ND12 in 1 BLISTER PACKTABLET123
51467-013-01COLTALIN-ND2 in 1 BOXTABLET23
51467-013-02COLTALIN-ND3 in 1 BOXTABLET33
51467-013-02COLTALIN-ND12 in 1 BLISTER PACKTABLET123

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51467-013COLTALIN-ND (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [FORTUNE PHARMACAL COMPANY LIMITED]1Current NDC, 4 package rows20241228_7373ad43-0afa-4d21-8afc-a737e9f19290.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 157 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy Multi SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.d49b42ad-0ae0-48c9-adba-5fc2ced977642024-08-12WarningsExact identifier
application number: M012
RYMEDDEXCHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDEEDWARDS PHARMACEUTICALS, INC.c1d6e914-74cc-4cdf-9587-7eaaa4a386e52024-08-12WarningsExact identifier
application number: M012
WesTussin DM NFWESTUSSIN DM NFWestminster Pharmaceuticals, LLC4e0f9f97-a31c-41ac-9d6c-d81efd20fcef2024-08-08WarningsExact identifier
application number: M012
Mucus Relief Sinus Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.2f2a2864-af11-4240-bdad-a54aca58d01b2024-08-07WarningsExact identifier
application number: M012
Cold plus Flu Congestion SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.0199aea2-a9c1-4c9d-8786-28b9dadc832e2024-08-07WarningsExact identifier
application number: M012
Mucus Relief Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.32d1ce6e-2617-4b50-a9e6-2e1941465dff2024-08-07WarningsExact identifier
application number: M012
Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.07362db5-a372-4463-af8b-06e8783ca8652024-08-07WarningsExact identifier
application number: M012
Head Congestion plus Flu Severe PEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.1fb11d90-48bf-4baa-9b3a-5d64d81e3a062024-08-07WarningsExact identifier
application number: M012
Mucus Relief Sinus Pressure Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.574774b2-9813-4799-9cd4-27e296dd85842024-08-07WarningsExact identifier
application number: M012
Cold Max Day and NIghtACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.a92bcefb-ba29-4b3f-a60b-b4476ca8cf042024-08-07WarningsExact identifier
application number: M012
Sinus plus HeadacheACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.778f1f5a-fd04-456f-90d0-998b93e774a52024-08-07WarningsExact identifier
application number: M012
Head Congestion plus Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.990f3232-bc75-45cf-8a50-cd7861d83f982024-08-07WarningsExact identifier
application number: M012
Mucus Relief Cold and Flu All in OneACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.0f5f25c6-7389-4285-b8d5-463cb7b6fcc42024-08-07WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATECare One (Retail Business Services, LLC.)a9a5b39d-b4c8-414e-8fe7-4c0601f751972024-08-05WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDEAmerican Health Packagingb94feeb6-f33f-410d-a9b0-776b1ccf34a92024-08-04WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDEAmerican Health Packaging4cd8aee3-5522-434b-a1b1-9591bed3e9a62024-08-04WarningsExact identifier
application number: M012
Guaifenesin DMGUAIFENESIN AND DEXTROMETHORPHANAmerican Health Packaging8632a655-7f5b-450f-95fa-62478a174e9c2024-08-04WarningsExact identifier
application number: M012
Guaifenesin DMGUAIFENESIN AND DEXTROMETHORPHANAmerican Health Packaging990906b3-c566-4f35-923c-060202ba48e02024-08-04WarningsExact identifier
application number: M012
Honey Lemon Flavor Cough DropsHONEY LEMON FLAVOR MENTHOLWHOLE FOODS MARKET, INC.1eb7abdc-061f-0e18-e063-6294a90a3a652024-08-02WarningsExact identifier
application number: M012
Herbal Flavor Menthol Cough DropsHERBAL FLAVOR MENTHOL COUGH DROPSWHOLE FOODS MARKET, INC.1eb848b6-3dec-5b5f-e063-6394a90aea142024-08-02WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046378acetaminophen 325 MG / phenylephrine HCl 5 MG Oral TabletPSN7373ad43-0afa-4d21-8afc-a737e9f192903
1046378acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD7373ad43-0afa-4d21-8afc-a737e9f192903
1046378APAP 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSY7373ad43-0afa-4d21-8afc-a737e9f192903

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51467-013-01514670013012 BLISTER PACK in 1 BOX (51467-013-01) / 12 TABLET in 1 BLISTER PACK2 blister pack2025-07-012029-06-30NoNoHistorical
51467-013-02514670013023 BLISTER PACK in 1 BOX (51467-013-02) / 12 TABLET in 1 BLISTER PACK3 blister pack2025-07-012029-06-30NoNoHistorical