Cough and Congestion DM

Product NDC
58805-007
11-digit product format
588050007
Labeler code
58805
Product ID
58805-007_4e88b254-c0b1-48bf-9ca5-b13a22118204
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan and Guaifenesin
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Agile Pharmachem
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-11-08
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
10 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58805-007-752020-01-31C16284748780-19d75b9cf-fb24-f424-e053-dadaa90a57ceChest and Cough Congestion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58805-007-75Cough and Congestion DM7500 in 1 CAPSULECAPSULE, LIQUID FILLED75001
58805-007-75Cough and Congestion DM1 in 1 CARTONCAPSULE, LIQUID FILLED11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCOUGH AND CONGESTION DM (DEXTROMETHORPHAN AND GUAIFENESIN) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]1
GUAIFENESINACTIVE INGREDIENT495W7451VQCOUGH AND CONGESTION DM (DEXTROMETHORPHAN AND GUAIFENESIN) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCOUGH AND CONGESTION DM (DEXTROMETHORPHAN AND GUAIFENESIN) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]1
GUAIFENESINACTIVE MOIETY495W7451VQCOUGH AND CONGESTION DM (DEXTROMETHORPHAN AND GUAIFENESIN) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACOUGH AND CONGESTION DM (DEXTROMETHORPHAN AND GUAIFENESIN) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]1
GELATININACTIVE INGREDIENT2G86QN327LCOUGH AND CONGESTION DM (DEXTROMETHORPHAN AND GUAIFENESIN) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCOUGH AND CONGESTION DM (DEXTROMETHORPHAN AND GUAIFENESIN) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]1
POLYETHYLENE GLYCOL 1000INACTIVE INGREDIENTU076Q6Q621COUGH AND CONGESTION DM (DEXTROMETHORPHAN AND GUAIFENESIN) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ECOUGH AND CONGESTION DM (DEXTROMETHORPHAN AND GUAIFENESIN) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XCOUGH AND CONGESTION DM (DEXTROMETHORPHAN AND GUAIFENESIN) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3COUGH AND CONGESTION DM (DEXTROMETHORPHAN AND GUAIFENESIN) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]1
SORBITOLINACTIVE INGREDIENT506T60A25RCOUGH AND CONGESTION DM (DEXTROMETHORPHAN AND GUAIFENESIN) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCOUGH AND CONGESTION DM (DEXTROMETHORPHAN AND GUAIFENESIN) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58805-007COUGH AND CONGESTION DM (DEXTROMETHORPHAN AND GUAIFENESIN) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]1Legacy NDC, 2 package rows20151113_1a7fa7fd-435f-4a94-9d7e-7b7e83e9f97e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111663dextromethorphan HBr 10 MG / guaiFENesin 200 MG Oral CapsulePSN1a7fa7fd-435f-4a94-9d7e-7b7e83e9f97e1
1111663dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG Oral CapsuleSCD1a7fa7fd-435f-4a94-9d7e-7b7e83e9f97e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
58805-007-75588050007757500 in 1 CAPSULEHistorical