FDA.reportPublic FDA data

COLDTAC ULTRA

Product NDC
69729-133
11-digit product format
697290133
Labeler code
69729
Product ID
69729-133_5d1ffdea-dd95-21e2-e063-6294a90a0bbe
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl
Dosage form
TABLET
Route
ORAL
Labeler
OPMX LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-10
Substance
PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE
Active strength
10; 500; 4 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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
COLDTAC ULTRA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE10 mg/1
ACETAMINOPHEN500 mg/1
CHLORPHENIRAMINE MALEATE4 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
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05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
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20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
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3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
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aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
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23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
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332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
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53855190-7124-8179-f018-e792f7c27f28Product name120140508
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cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
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d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
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e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69729-133-06COLDTAC ULTRA2 in 1 POUCHTABLET22
69729-133-06COLDTAC ULTRA3 in 1 CARTONTABLET32
69729-133-27COLDTAC ULTRA2 in 1 POUCHTABLET22
69729-133-37COLDTAC ULTRA2 in 1 POUCHTABLET22
69729-133-37COLDTAC ULTRA6 in 1 CARTONTABLET62
69729-133-38COLDTAC ULTRA72 in 1 CARTONTABLET722
69729-133-38COLDTAC ULTRA2 in 1 POUCHTABLET22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69729-133COLDTAC ULTRA (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [OPMX LLC]2Current NDC, 7 package rows20240127_0e9d506d-8c0c-ab6b-e063-6294a90a5ab6.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 168 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Theraflu ExpressMax Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLHaleon US Holdings LLCf5a66541-1b15-4dfe-91e0-d8d5f8fdc7fb2024-03-07WarningsExact identifier
application number: M012
Theraflu ExpressMax Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLHaleon US Holdings LLC62f7fcb9-e31a-4634-b1c2-44a9567e3a612024-03-07WarningsExact identifier
application number: M012
Theraflu ExpressMax Severe Cold and Flu CapletsACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLHaleon US Holdings LLC8e22f6bc-33ce-4bb0-99be-7947aa21f60e2024-03-07WarningsExact identifier
application number: M012
Theraflu ExpressMax Severe Cold and Flu SyrupACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLHaleon US Holdings LLC777d2ac7-e3cc-4513-8b6f-b90b2ff2c6722024-03-07WarningsExact identifier
application number: M012
Childrens Cold and AllergyBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLCVS Pharmacy4c6025ff-4982-4408-b077-75dd5f5b65b22024-03-07WarningsExact identifier
application number: M012
Daytime Cold and Flu Non DrowsyACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS Pharmacy423fd5e6-5d90-4539-81e0-0ae23881ee3a2024-03-07WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS Pharmacy917df706-1982-4240-9f56-42d426b76cc52024-03-06WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCare One (Retail Business Services, LLC.)21a29998-29d6-4a36-a370-291d23bfb1972024-03-05WarningsExact identifier
application number: M012
Multi-Symptom Cold and Flu DayTimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCare One (Retail Business Services, LLC.)3c7ef3cf-f7f9-42bc-bf20-e36954b9671f2024-03-05WarningsExact identifier
application number: M012
QUALITY CHOICE NightTime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEChain Drug Marketing Association, Inc.da06e994-6848-4c1e-9432-31de5e626ea42024-03-02WarningsExact identifier
application number: M012
QUALITY CHOICE DayTime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEChain Drug Marketing Association, Inc.417c4fa9-6458-40d0-b22a-2415194e250f2024-03-02WarningsExact identifier
application number: M012
DAYTIME COLD AND FLU MULTI-SYMPTOM RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEAurohealth LLC8eaa0eec-cc52-4f1f-8ddb-06c54d577ce22024-03-01WarningsExact identifier
application number: M012
APRODINEPSEUDOEPHEDRINE HCL, TRIPROLIDINE HCLA-S Medication Solutionsbbc268b8-fa66-4dc5-b935-f77ae39d28c82024-02-29WarningsExact identifier
application number: M012
XtraCare Vaporizing Chest RubCAMPHOR, MENTHOLRejoice Internationalc3e220d6-fff4-452f-99a9-bd701fc608a02024-02-28WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Daytime Berry BurstACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLCebbb2f4b-ba84-40ad-96f6-60225119a33b2024-02-27WarningsExact identifier
application number: M012
Mucus Relief Sinus Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEAMERISOURCE BERGEN1c93c45d-1141-4599-83ba-6d3b38f9ffc42024-02-23WarningsExact identifier
application number: M012
Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEAmeriSource Bergen3dc293c9-736b-4bd8-b993-ff83b9909bcd2024-02-23WarningsExact identifier
application number: M012
Childrens Dibromm Cold and AllergyBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLCardinal Health (Leader) 7000010cc7d67-30c4-4451-bf74-78abae3c8e252024-02-23WarningsExact identifier
application number: M012
Nasal Spray, 24-7 for LifeOXYMETAZOLINE HYDROCHLORIDE 0.05%Lil' Drug Store Products, Inc.11d27c75-fd95-f9da-e063-6394a90ac6b02024-02-20WarningsExact identifier
application number: M012
Nighttime Cold and Cough childrensDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLBest Choice (Valu Merchandisers Company)11652e8a-2242-4449-8a41-a8e75509025e2024-02-20WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2463332acetaminophen 500 MG / chlorpheniramine maleate 4 MG / phenylephrine HCl 10 MG Oral TabletPSN0e9d506d-8c0c-ab6b-e063-6294a90a5ab62
2463332acetaminophen 500 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral TabletSCD0e9d506d-8c0c-ab6b-e063-6294a90a5ab62
2463332APAP 500 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral TabletSY0e9d506d-8c0c-ab6b-e063-6294a90a5ab62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69729-133-06697290133063 POUCH in 1 CARTON (69729-133-06) / 2 TABLET in 1 POUCH3 pouch2024-01-10NoNoCurrent
69729-133-27697290133272 TABLET in 1 POUCH (69729-133-27) 2 tablet2024-01-10NoNoCurrent
69729-133-37697290133376 POUCH in 1 CARTON (69729-133-37) / 2 TABLET in 1 POUCH6 pouch2024-01-10NoNoCurrent
69729-133-386972901333872 POUCH in 1 CARTON (69729-133-38) / 2 TABLET in 1 POUCH72 pouch2024-01-10NoNoCurrent
69729-133-506972901335050 POUCH in 1 CARTON (69729-133-50) / 2 TABLET in 1 POUCH50 pouch2026-07-23NoNoCurrent