NDC 49580-0385-08 - Tussin DM Cough and Chest Congestion Adult

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
49580-0385
Requested NDC
49580-0385-08
Package NDCs from labels
49580-0385-4, 49580-0385-2, 49580-0385-8, 49580-0385-08
Manufacturer
P & L Development, LLC
Effective date
2025-10-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tussin DM Cough and Chest Congestion Adult - P & L Development, LLCP & L Development, LLC2025-10-28HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49580-0385-2Tussin DM Cough and Chest CongestionAdult118 mL in 1 BOTTLE, PLASTICLIQUID11814
49580-0385-4Tussin DM Cough and Chest CongestionAdult118 mL in 1 BOTTLE, PLASTICLIQUID11814
49580-0385-4Tussin DM Cough and Chest CongestionAdult1 in 1 BOXLIQUID114
49580-0385-8Tussin DM Cough and Chest CongestionAdult1 in 1 BOXLIQUID114
49580-0385-8Tussin DM Cough and Chest CongestionAdult237 mL in 1 BOTTLE, PLASTICLIQUID23714

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49580-0385TUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [P & L DEVELOPMENT, LLC]11Current NDC, Legacy NDC, 5 package rows20240127_4af67ba7-8892-442c-b9fb-80aba9140e05.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHTUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.]1
GUAIFENESINACTIVE INGREDIENT495W7451VQTUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSTUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.]1
GUAIFENESINACTIVE MOIETY495W7451VQTUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLTUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.]1
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2TUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6STUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.]1
MENTHOL, UNSPECIFIED FORMINACTIVE INGREDIENTL7T10EIP3ATUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYTUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUTUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RTUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.]1

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 7 of 321 · 6,418 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Multi-Symptom AllergyACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLWalgreen Company5170c450-989d-44fa-ab38-86c78feae3b62026-08-28WarningsExact identifier
application number: M012
Maximum Strength Mucus Relief DMGUAIFENESIN AND DEXTROMETHORPHAN HBRWal-Mart Stores, Inc.ff7280e7-804b-423d-add8-54ec2c76fca22026-08-28WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINWalgreen Companyd8a693f7-03c1-4583-89a8-8d506a894b242026-08-28WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Pain Reliever PM Extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreens54cbbc5f-908b-47b2-b37f-3646354d35682026-08-27WarningsExact identifier
application number: M012
Maximum Strength Mucus ReliefDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLHyvee Inc4e578c7a-88d4-e4cd-e063-6394a90aac442026-08-27WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 495W7451VQ
MUCUS RELIEFGUAIFENESINGeri-Care Pharmaceuticals, Corp5afb242f-fac9-dc81-e063-6394a90a84482026-08-27WarningsExact identifier
application number: M012
unii: 495W7451VQ
daytime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEAmazon.com Services LLC6de619d3-0ab0-43e7-8dac-7bbd5368ac652026-08-27WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Daytime Mucus Relief Severe Congestion and Cough and Nighttime Cold and Flu Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCIWalgreens366ddac8-9e8a-41bd-a7f7-48213485a5f82026-08-27WarningsExact identifier
application number: M012
Good Sense Cough DMDEXTROMETHORPHAN POLISTIREXL. Perrigo Company5a2e9bef-42cb-4b72-9a26-c3ae71dcb4ea2026-08-27WarningsExact identifier
unii: 9D2RTI9KYH
Nighttime Cold and Flu Maximum StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCIWalgreens37896933-3ed3-457f-8a32-ee0d784a19e82026-08-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEAmazon.com Services LLC298e9164-e378-4b39-a944-bfc8f8baa4de2026-08-27WarningsExact identifier
application number: M012
DayTime Mucus Relief Severe Cold and Nighttime Cold and Flu Maximum StrengthDAYTIME ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, NIGHTTIME ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCIWalgreens3b4b3b04-eff9-4e06-8b37-f6729671d07f2026-08-27WarningsExact identifier
application number: M012
Careland Lidocaine Plus Menthol Pain RelievingLIDOCAINE, MENTHOLPlanet (Anhui) Pharmaceutical Co., Ltd0f928b5b-60f5-4a45-a409-c601eb3304872026-08-26WarningsExact identifier
unii: L7T10EIP3A
PARCHE CALIENTECAPSAICINA AND MENTOLDW SUPPORT LLC59f2708e-295a-ccb3-e063-6394a90ad3952026-08-26WarningsExact identifier
unii: L7T10EIP3A
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Daytime Cold and Flu mini SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corpdfb0fe2e-b0c7-409a-bd1a-fd12485665ba2026-08-26WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Nighttime Severe Cold and Flu Maximum Strength mini softgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLShield Pharmaceuticals Corp70c5517d-be4e-4317-b4f4-df660c71c6992026-08-26WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.c1f9ec75-7eb2-405c-8cdc-097cbf2cf87d2026-08-26WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 495W7451VQ
robafen dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINPreferred Pharmaceuticals Inc.5b2fd5ce-56ab-491a-81b9-44e35a5d23162026-08-26WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Childrens TYLENOL COLD plus COUGH plus RUNNY NOSEACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC5b95905e-b729-4caf-921a-fc4ef815289c2026-08-25WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.