FDA.reportPublic FDA data

GUAAP

Product NDC
46084-051
11-digit product format
460840051
Labeler code
46084
Product ID
46084-051_b4133ea4-5e75-46d7-80b4-e7350c8ce234
Type
HUMAN OTC DRUG
Nonproprietary name
GUAIFENESIN
Dosage form
LIQUID
Route
ORAL
Labeler
A P J Laboratories Limited
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-03-01
Marketing end
0000-00-00
Substance
GUAIFENESIN
Active strength
100 mg/5mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46084-051-212019-11-27C16284748780-19855d018-d59b-cd31-e053-dbdaa90ab51a6f6f3aae-a676-4b91-bad3-2a1c798ffe0a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46084-051-21GUAAP120 mL in 1 BOTTLELIQUID1201

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GUAIFENESINACTIVE INGREDIENT495W7451VQGUAAP (GUAIFENESIN) LIQUID [A P J LABORATORIES LIMITED]1
GUAIFENESINACTIVE MOIETY495W7451VQGUAAP (GUAIFENESIN) LIQUID [A P J LABORATORIES LIMITED]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1GUAAP (GUAIFENESIN) LIQUID [A P J LABORATORIES LIMITED]1
BRONOPOLINACTIVE INGREDIENT6PU1E16C9WGUAAP (GUAIFENESIN) LIQUID [A P J LABORATORIES LIMITED]1
EDETIC ACIDINACTIVE INGREDIENT9G34HU7RV0GUAAP (GUAIFENESIN) LIQUID [A P J LABORATORIES LIMITED]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3AGUAAP (GUAIFENESIN) LIQUID [A P J LABORATORIES LIMITED]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUGUAAP (GUAIFENESIN) LIQUID [A P J LABORATORIES LIMITED]1
SORBITOLINACTIVE INGREDIENT506T60A25RGUAAP (GUAIFENESIN) LIQUID [A P J LABORATORIES LIMITED]1
SUCROSEINACTIVE INGREDIENTC151H8M554GUAAP (GUAIFENESIN) LIQUID [A P J LABORATORIES LIMITED]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEGUAAP (GUAIFENESIN) LIQUID [A P J LABORATORIES LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46084-051GUAAP (GUAIFENESIN) LIQUID [A P J LABORATORIES LIMITED]1Legacy NDC, 1 package rows20130301_6f6f3aae-a676-4b91-bad3-2a1c798ffe0a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN6f6f3aae-a676-4b91-bad3-2a1c798ffe0a1
310604guaifenesin 20 MG/ML Oral SolutionSCD6f6f3aae-a676-4b91-bad3-2a1c798ffe0a1
310604guaifenesin 100 MG per 5 ML Oral SolutionSY6f6f3aae-a676-4b91-bad3-2a1c798ffe0a1
310604guaifenesin 100 MG per 5 ML Oral SyrupSY6f6f3aae-a676-4b91-bad3-2a1c798ffe0a1
310604guaifenesin 200 MG per 10 ML Oral SolutionSY6f6f3aae-a676-4b91-bad3-2a1c798ffe0a1
310604guaifenesin 300 MG per 15 ML Oral SolutionSY6f6f3aae-a676-4b91-bad3-2a1c798ffe0a1
310604guaifenesin 400 MG per 20 ML Oral SolutionSY6f6f3aae-a676-4b91-bad3-2a1c798ffe0a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
46084-051-2146084005121120 mL in 1 BOTTLE120 mlHistorical