Home NDC 0113-0335 good sense night time
Product NDC 0113-0335
11-digit product format 001130335
Labeler code 0113
Product ID 0113-0335_7f4d7b4d-ab26-4c6e-bf29-c34afc8833d3
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
Dosage form SOLUTION
Route ORAL
Labeler L. Perrigo Company
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2011-08-19
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL
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 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 Ingredient Strength ACETAMINOPHEN 650 mg/30mL DEXTROMETHORPHAN HYDROBROMIDE 30 mg/30mL DOXYLAMINE SUCCINATE 12.5 mg/30mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup 9D2RTI9KYH Internal UNII lookup V9BI9B5YI2 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1043400 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0113-0335-30 good sense night time 177 mL in 1 BOTTLE SOLUTION 177 10 0113-0335-34 good sense night time 237 mL in 1 BOTTLE SOLUTION 237 10 0113-0335-38 good sense night time 296 mL in 1 BOTTLE SOLUTION 296 10 0113-0335-40 good sense night time 354 mL in 1 BOTTLE SOLUTION 354 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D GOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [L. PERRIGO COMPANY] 4 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH GOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [L. PERRIGO COMPANY] 4 DOXYLAMINE SUCCINATE ACTIVE INGREDIENT V9BI9B5YI2 GOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [L. PERRIGO COMPANY] 4 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D GOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [L. PERRIGO COMPANY] 4 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS GOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [L. PERRIGO COMPANY] 4 DOXYLAMINE ACTIVE MOIETY 95QB77JKPL GOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [L. PERRIGO COMPANY] 4 ALCOHOL INACTIVE INGREDIENT 3K9958V90M GOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [L. PERRIGO COMPANY] 4 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL GOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [L. PERRIGO COMPANY] 4 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G GOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [L. PERRIGO COMPANY] 4 FD&C GREEN NO. 3 INACTIVE INGREDIENT 3P3ONR6O1S GOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [L. PERRIGO COMPANY] 4 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 GOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [L. PERRIGO COMPANY] 4 HIGH FRUCTOSE CORN SYRUP INACTIVE INGREDIENT XY6UN3QB6S GOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [L. PERRIGO COMPANY] 4 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A GOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [L. PERRIGO COMPANY] 4 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 GOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [L. PERRIGO COMPANY] 4 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY GOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [L. PERRIGO COMPANY] 4 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR GOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [L. PERRIGO COMPANY] 4 WATER INACTIVE INGREDIENT 059QF0KO0R GOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [L. PERRIGO COMPANY] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0113-0335 GOOD SENSE NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [L. PERRIGO COMPANY] 9 Current NDC, Legacy NDC, 4 package rows 20241027_0c79357a-b79d-4952-8e6d-ef3d60dde2fa.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 130 of 178 · 3,550 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Kroger Daytime Cold and Flu Softgel ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE The Kroger Company e428dd83-c538-2a92-e053-2a95a90a0e16 2024-12-13 Warnings Exact identifier application number: M012 Kroger Nighttime Cold and Flu Softgel ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE The Kroger Company e46291c7-6f4d-46a2-e053-2a95a90a80a1 2024-12-13 Warnings Exact identifier application number: M012 Foster and Thrive Childrens Allergy Relief DIPHENHYDRAMINE HCL Strategic Sourcing Services LLC 7eaba464-5cdb-4bd4-b272-38fa108658d5 2024-12-13 Warnings Exact identifier application number: M012 SUDAFED OM Sinus Severe Original OXYMETAZOLINE HYDROCHLORIDE Kenvue Brands LLC 1d089074-3969-ce6e-e063-6294a90aa70c 2024-12-12 Warnings Exact identifier application number: M012 RIGHT REMEDIES Allergy Relief DIPHENHYDRAMINE HYDROCHLORIDE Strive Pharmaceuticals Inc b4fc014c-7c5f-46a4-bf13-57103b6fa018 2024-12-11 Warnings Exact identifier application number: M012 Diphenhydramine Hydrochloride 25mg DIPHENHYDRAMINE HYDROCHLORIDE 25MG Strive Pharmaceuticals Inc b440eb2e-4de9-2b65-e053-2995a90abda8 2024-12-11 Warnings Exact identifier application number: M012 Meijer Effervescent Cold Relief ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE Meijer Distribution Inc. 6933ca9d-a32d-d856-e053-2a91aa0a408e 2024-12-10 Warnings Exact identifier application number: M012 Effervescent Orange Cold Relief ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE Meijer Distribution Inc. 826b5c0d-7a75-bbf0-e053-2a91aa0aebd6 2024-12-10 Warnings Exact identifier application number: M012 DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola USA Inc. 09141018-37ba-4c93-9051-1ed129c448c1 2024-12-10 Warnings Exact identifier application number: M012 Original Herb Cough Drops MENTHOL Ricola USA Inc. 6ac9d95b-f6b9-4515-b126-697f8f839612 2024-12-10 Warnings Exact identifier application number: M012 THE ORIGINAL NATURAL HERB COUGH DROPS MENTHOL Ricola USA Inc. 989d1529-2875-47bf-81df-65494d62be7a 2024-12-10 Warnings Exact identifier application number: M012 DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola USA Inc. 82813342-2be2-4731-ae90-dbd5eed667a9 2024-12-10 Warnings Exact identifier application number: M012 MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola USA Inc. b640a5d2-a7fe-486d-a65f-e7c993f950d6 2024-12-10 Warnings Exact identifier application number: M012 Sugar Free Mountain Herb Cough Suppressant Throat Drops MENTHOL Ricola USA Inc. c3f3c062-55e5-43c1-a016-ee47a7b388a5 2024-12-10 Warnings Exact identifier application number: M012 RICOLA MAX THROAT CARE SWISS CHERRY MENTHOL Ricola USA Inc. ee4733b5-6e5a-438a-97da-110f3ef6c809 2024-12-10 Warnings Exact identifier application number: M012 SUGAR FREE GREEN TEA WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS MENTHOL Ricola USA Inc. f62fcc38-2d43-40b3-841f-c8eea9ebd1e1 2024-12-10 Warnings Exact identifier application number: M012 DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola USA Inc. 8a6db093-7e52-443f-8dd6-94867606fef8 2024-12-10 Warnings Exact identifier application number: M012 RICOLA MAX THROAT CARE COOL PEPPERMINT MENTHOL Ricola USA Inc. 5885343e-4a6e-44f7-87a4-d52599156197 2024-12-10 Warnings Exact identifier application number: M012 EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT MENTHOL Ricola USA Inc. 0baf383c-886d-47ca-8a6d-221298c79446 2024-12-10 Warnings Exact identifier application number: M012 Tussin Multi Symptom Cold CF DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE Best Choice (Valu Merchandisers Company) 539b8972-2a46-468e-ad27-6672d746feb7 2024-12-10 Warnings Exact identifier application number: M012
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0113-0335-30 00113033530 177 mL in 1 BOTTLE (0113-0335-30) 177 ml 2011-08-19 0000-00-00 No No Current 0113-0335-34 00113033534 237 mL in 1 BOTTLE (0113-0335-34) 237 ml 2012-07-20 0000-00-00 No No Current 0113-0335-38 00113033538 296 mL in 1 BOTTLE (0113-0335-38) 296 ml 2011-09-20 0000-00-00 No No Current 0113-0335-40 00113033540 354 mL in 1 BOTTLE (0113-0335-40) 354 ml 2012-08-20 0000-00-00 No No Current