FDA.reportPublic FDA data

Daytime Cold and Flu

Product NDC
66715-6715
11-digit product format
667156715
Labeler code
66715
Product ID
66715-6715_46a0a829-493c-a0c5-e063-6294a90af13e
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Lil' Drug Store Products, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-09-05
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 15; 5 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], 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
Daytime Cold and Flu
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE15 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 9D2RTI9KYH, 04JA59TNSJ
Rxcui1312260

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
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
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
66715-6715-8Daytime Cold and Flu2 in 1 BLISTER PACKCAPSULE, LIQUID FILLED24
66715-6715-8Daytime Cold and Flu8 in 1 CARTONCAPSULE, LIQUID FILLED84

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-6715DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [LIL' DRUG STORE PRODUCTS, INC.]3Current NDC, Legacy NDC, 2 package rows20241127_5b493ed7-9044-4841-9935-236d0bdc71a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1312260acetaminophen 325 MG / dextromethorphan HBr 15 MG / phenylephrine HCl 5 MG Oral CapsulePSN5b493ed7-9044-4841-9935-236d0bdc71a94
1312260acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD5b493ed7-9044-4841-9935-236d0bdc71a94
1312260APAP 325 MG / Dextromethorphan Hydrobromide 15 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSY5b493ed7-9044-4841-9935-236d0bdc71a94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66715-6715-8667156715088 BLISTER PACK in 1 CARTON (66715-6715-8) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK8 blister pack2020-02-150000-00-00NoNoCurrent