FDA.reportPublic FDA data

good sense night time

Product NDC
0113-0056
11-digit product format
001130056
Labeler code
0113
Product ID
0113-0056_fea7bdc4-66c7-4a30-8128-7f2a0d2d609c
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
L. Perrigo Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-05-30
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
325; 15; 6.25 mg/1; mg/1; mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0113-00560113-0056-51DDiscontinued by firm2026-10-23

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…

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
good sense night time
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE15 mg/1
DOXYLAMINE SUCCINATE6.25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
9D2RTI9KYHInternal UNII lookup
V9BI9B5YI2Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1094549Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e47dffdf-5778-4804-8ce2-54c5a72bba3aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0113-0056-51good sense night time4 in 1 CARTONCAPSULE, LIQUID FILLED48
0113-0056-51good sense night time2 in 1 BLISTER PACKCAPSULE, LIQUID FILLED28
0113-0056-62good sense night time2 in 1 BLISTER PACKCAPSULE, LIQUID FILLED28
0113-0056-62good sense night time12 in 1 CARTONCAPSULE, LIQUID FILLED128
0113-0056-67good sense night time24 in 1 CARTONCAPSULE, LIQUID FILLED248
0113-0056-67good sense night time2 in 1 BLISTER PACKCAPSULE, LIQUID FILLED28
0113-0056-73good sense night time8 in 1 CARTONCAPSULE, LIQUID FILLED88
0113-0056-73good sense night time2 in 1 BLISTER PACKCAPSULE, LIQUID FILLED28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0056-51EA - Each0113-0056d80b7088-2fd9-4cc5-bd73-85ffa53a6ee812018-02-20
0113-0056-62EA - Each0113-00566a797dff-9ec1-4629-9a90-89043f3b3efa12021-07-15
0113-0056-73EA - Each0113-005677c4dcde-a68d-4782-9dbe-33fda7e914d712021-07-15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DGOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [L. PERRIGO COMPANY]2
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHGOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [L. PERRIGO COMPANY]2
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2GOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [L. PERRIGO COMPANY]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DGOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [L. PERRIGO COMPANY]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSGOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [L. PERRIGO COMPANY]2
DOXYLAMINEACTIVE MOIETY95QB77JKPLGOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [L. PERRIGO COMPANY]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [L. PERRIGO COMPANY]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [L. PERRIGO COMPANY]2
GELATININACTIVE INGREDIENT2G86QN327LGOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [L. PERRIGO COMPANY]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXGOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [L. PERRIGO COMPANY]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [L. PERRIGO COMPANY]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EGOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [L. PERRIGO COMPANY]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [L. PERRIGO COMPANY]2
WATERINACTIVE INGREDIENT059QF0KO0RGOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [L. PERRIGO COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0056GOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [L. PERRIGO COMPANY]7Current NDC, Legacy NDC, 8 package rows20241018_e47dffdf-5778-4804-8ce2-54c5a72bba3a.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 67 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucus Relief DMDEXTROMETHORPHAN HBR 20MG GUAIFENESIN 400MGPioneer Life Sciences, LLC3ce0f096-906e-47eb-8061-0ac1e9d8ea552025-12-26WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESIN 400 MGPioneer Life Sciences, LLC1194c338-e115-4105-93d8-9ab833c431932025-12-26WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESIN 400 MGPioneer Life Sciences, LLC9c9e558d-d991-4a2e-aa13-37c0b08071e62025-12-26WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESIN 400 MGPioneer Life Sciences, LLC1695e7ea-2f83-4d3a-980e-c91be6c1f2a52025-12-25WarningsExact identifier
application number: M012
GUAIFENESINGUAIFENESINPharbest Pharmaceuticals, Inc.0bf70fb4-d3c8-476d-b864-4eadc697a7d82025-12-24WarningsExact identifier
application number: M012
PHARBINEX-DMGUAIFENESIN 400MG AND DEXTROMETHORPHAN HBR 20MGPharbest Pharmaceuticals, Inc.8d71db43-da87-45ee-aa4a-7e870bc5016d2025-12-24WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLSafeway, Inc.764bcc58-bc5f-4ee6-82b7-cb0ed5baf3be2025-12-23WarningsExact identifier
application number: M012
TussinGUAIFENESINDiscount Drug Mart14de3d6d-4eb0-42cf-8941-cb42b3dd5c712025-12-23WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCL 25 MGPioneer Life Sciences, LLCc8dcba06-a461-4af5-a120-666a63f06ac42025-12-23WarningsExact identifier
application number: M012
SAFETUSSIN MAX STRENGTH MS Cough, Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESINKRAMER LABORATORIES920bde5f-4079-45de-aa59-24b00e50cb562025-12-23WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEHumanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd46996bbf-948c-0aba-e063-6394a90a09e32025-12-23WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATELil' Drug Store Products, Inc.1d2e2a5a-099b-41b3-82bd-5bf704377f782025-12-23WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDELil' Drug Store Products, Inc.5b493ed7-9044-4841-9935-236d0bdc71a92025-12-23WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDELil' Drug Store Products, Inc.77a7ff9a-a414-4053-8d8d-369907d4380d2025-12-23WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATELil' Drug Store Products, Inc.8f320235-f243-4211-b99c-18526e6865482025-12-23WarningsExact identifier
application number: M012
Circle K Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDELil' Drug Store Products, Inc.b6a46498-d9a8-4da2-9283-57d135f305a52025-12-23WarningsExact identifier
application number: M012
Circle K Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATELil' Drug Store Products, Inc.7c5faec2-28c6-4c15-a268-d8b578140b742025-12-23WarningsExact identifier
application number: M012
Sugar Free Honey Lemon Cough DropsMENTHOLWalmart67650b94-adbb-87fb-e053-2a91aa0a87e62025-12-23WarningsExact identifier
application number: M012
Equate Benz-Dex Cough and Throat LozengesBENZOCAINEWalmartc0a6cb7f-a247-e610-e053-2a95a90a41992025-12-23WarningsExact identifier
application number: M012
Equate Honey Lemon Cough DropsMENTHOLWalMart0028be18-5162-ff51-e063-6294a90ae5172025-12-23WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094549acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral CapsulePSNe47dffdf-5778-4804-8ce2-54c5a72bba3a8
1094549acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSCDe47dffdf-5778-4804-8ce2-54c5a72bba3a8
1094549APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSYe47dffdf-5778-4804-8ce2-54c5a72bba3a8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0056-51001130056514 BLISTER PACK in 1 CARTON (0113-0056-51) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK4 blister pack2016-08-100000-00-00NoNoCurrent
0113-0056-620011300566212 BLISTER PACK in 1 CARTON (0113-0056-62) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK12 blister pack2014-08-250000-00-00NoNoCurrent
0113-0056-670011300566724 BLISTER PACK in 1 CARTON (0113-0056-67) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK24 blister pack2026-01-08NoNoCurrent
0113-0056-73001130056738 BLISTER PACK in 1 CARTON (0113-0056-73) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK8 blister pack2014-05-300000-00-00NoNoCurrent