FDA.reportPublic FDA data

Guaifenesin and Pseudoephedrine Hydrochloride

Product NDC
51660-071
11-digit product format
516600071
Labeler code
51660
Product ID
51660-071_e0cbdc72-78c1-4372-a09d-de74c383dbbf
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Pseudoephedrine Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
OHM LABORATORIES INC
Application
NDA021585
Marketing category
NDA
Marketing start
2017-11-15
Marketing end
0000-00-00
Substance
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
600 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51660-071-182024-01-30C16284748780-11030e365-2bb1-111a-e063-dadaa90a10e2Guaifenesin and Pseudoephedrine Hydrochloride
51660-071-362024-01-30C16284748780-11030e365-2bb1-111a-e063-dadaa90a10e2Guaifenesin and Pseudoephedrine Hydrochloride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51660-071-18Guaifenesin and Pseudoephedrine Hydrochloride1 in 1 CARTONTABLET, EXTENDED RELEASE15
51660-071-18Guaifenesin and Pseudoephedrine Hydrochloride18 in 1 BLISTER PACKTABLET, EXTENDED RELEASE185
51660-071-36Guaifenesin and Pseudoephedrine Hydrochloride2 in 1 CARTONTABLET, EXTENDED RELEASE25
51660-071-36Guaifenesin and Pseudoephedrine Hydrochloride18 in 1 BLISTER PACKTABLET, EXTENDED RELEASE185

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51660-071GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [OHM LABORATORIES INC]5Legacy NDC, 4 package rows20190625_400252ae-fe27-4f82-87f3-ead7eff335de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305603guaiFENesin 600 MG / pseudoephedrine HCl 60 MG 12HR Extended Release Oral TabletPSN400252ae-fe27-4f82-87f3-ead7eff335de5
130560312 HR guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG Extended Release Oral TabletSCD400252ae-fe27-4f82-87f3-ead7eff335de5
1305603guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG 12 HR Extended Release Oral TabletSY400252ae-fe27-4f82-87f3-ead7eff335de5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51660-071-18516600071181 BLISTER PACK in 1 CARTON (51660-071-18) > 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2017-12-100000-00-00NoNoCurrent
51660-071-36516600071362 BLISTER PACK in 1 CARTON (51660-071-36) > 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2017-12-100000-00-00NoNoCurrent