Cold Terminator

Product NDC
84269-2556
11-digit product format
842692556
Labeler code
84269
Product ID
84269-2556_cde81c1b-0cf3-4d7b-af00-fb6a69419108
Type
HUMAN OTC DRUG
Nonproprietary name
PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Wildman Business Group
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-01
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 10; 100; 5 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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
Cold Terminator
Brand name suffix
Cold Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE10 mg/1
GUAIFENESIN100 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
Rxcui1098435

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84269-2556-1Cold Terminator Cold Relief50 in 1 BOXTABLET, FILM COATED501
84269-2556-1Cold Terminator Cold Relief2 in 1 PACKETTABLET, FILM COATED21
84269-2556-2Cold Terminator Cold Relief75 in 1 BOXTABLET, FILM COATED751
84269-2556-2Cold Terminator Cold Relief2 in 1 PACKETTABLET, FILM COATED21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84269-2556COLD TERMINATOR COLD RELIEF (PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) TABLET, FILM COATED [WILDMAN BUSINESS GROUP]1Current NDC, 4 package rows20240701_e8538d9c-f9ba-40b1-b60f-f57921f39b64.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1098435acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 100 MG / phenylephrine HCl 5 MG Oral TabletPSNe8538d9c-f9ba-40b1-b60f-f57921f39b641
1098435acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDe8538d9c-f9ba-40b1-b60f-f57921f39b641
1098435APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 100 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSYe8538d9c-f9ba-40b1-b60f-f57921f39b641

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84269-2556-18426925560150 PACKET in 1 BOX (84269-2556-1) / 2 TABLET, FILM COATED in 1 PACKET50 packet2024-07-01NoNoHistorical
84269-2556-28426925560275 PACKET in 1 BOX (84269-2556-2) / 2 TABLET, FILM COATED in 1 PACKET75 packet2024-07-01NoNoHistorical