FDA.reportPublic FDA data

good sense daytime

Product NDC
0113-0994
11-digit product format
001130994
Labeler code
0113
Product ID
0113-0994_8cc8d5fc-5247-4efa-87a1-e2cf659e9d91
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
L. Perrigo Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-01-18
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 10; 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
good sense daytime
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 9D2RTI9KYH, 04JA59TNSJ
Rxcui1086997

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
0113-0994-51good sense daytime2 in 1 BLISTER PACKCAPSULE, LIQUID FILLED228
0113-0994-51good sense daytime4 in 1 CARTONCAPSULE, LIQUID FILLED428
0113-0994-53good sense daytime6 in 1 CARTONCAPSULE, LIQUID FILLED628
0113-0994-53good sense daytime2 in 1 BLISTER PACKCAPSULE, LIQUID FILLED228
0113-0994-60good sense daytime10 in 1 CARTONCAPSULE, LIQUID FILLED1028
0113-0994-60good sense daytime2 in 1 BLISTER PACKCAPSULE, LIQUID FILLED228
0113-0994-62good sense daytime2 in 1 BLISTER PACKCAPSULE, LIQUID FILLED228
0113-0994-62good sense daytime12 in 1 CARTONCAPSULE, LIQUID FILLED1228
0113-0994-73good sense daytime8 in 1 CARTONCAPSULE, LIQUID FILLED828
0113-0994-73good sense daytime2 in 1 BLISTER PACKCAPSULE, LIQUID FILLED228

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0994-51EA - Each0113-0994598a81ea-ddbf-4846-9bf8-f9c3e985cb5412018-02-20
0113-0994-62EA - Each0113-0994a368927f-2f97-4c07-980f-a2d0569eb98512018-02-20
0113-0994-73EA - Each0113-099435dc3b78-5445-4a1e-8c7d-bfd1a2b4997012018-02-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DGOOD SENSE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [L. PERRIGO COMPANY]23
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHGOOD SENSE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [L. PERRIGO COMPANY]23
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJGOOD SENSE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [L. PERRIGO COMPANY]23
ACETAMINOPHENACTIVE MOIETY362O9ITL9DGOOD SENSE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [L. PERRIGO COMPANY]23
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSGOOD SENSE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [L. PERRIGO COMPANY]23
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVGOOD SENSE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [L. PERRIGO COMPANY]23
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGOOD SENSE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [L. PERRIGO COMPANY]23
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8GOOD SENSE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [L. PERRIGO COMPANY]23
GELATININACTIVE INGREDIENT2G86QN327LGOOD SENSE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [L. PERRIGO COMPANY]23
GLYCERININACTIVE INGREDIENTPDC6A3C0OXGOOD SENSE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [L. PERRIGO COMPANY]23
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGOOD SENSE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [L. PERRIGO COMPANY]23
POVIDONESINACTIVE INGREDIENTFZ989GH94EGOOD SENSE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [L. PERRIGO COMPANY]23
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GOOD SENSE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [L. PERRIGO COMPANY]23
WATERINACTIVE INGREDIENT059QF0KO0RGOOD SENSE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [L. PERRIGO COMPANY]23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0994GOOD SENSE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [L. PERRIGO COMPANY]28Current NDC, Legacy NDC, 10 package rows20250112_5ddf3283-94e4-465d-842a-471ee946c330.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSN5ddf3283-94e4-465d-842a-471ee946c33028
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD5ddf3283-94e4-465d-842a-471ee946c33028
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY5ddf3283-94e4-465d-842a-471ee946c33028

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0994-51001130994514 BLISTER PACK in 1 CARTON (0113-0994-51) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK4 blister pack2016-08-100000-00-00NoNoCurrent
0113-0994-53001130994536 in 1 CARTONHistorical
0113-0994-600011309946010 in 1 CARTONHistorical
0113-0994-620011309946212 BLISTER PACK in 1 CARTON (0113-0994-62) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK12 blister pack2012-09-060000-00-00NoNoCurrent
0113-0994-73001130994738 BLISTER PACK in 1 CARTON (0113-0994-73) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK8 blister pack2012-09-140000-00-00NoNoCurrent