FDA.reportPublic FDA data

good sense allergy

Product NDC
0113-0379
11-digit product format
001130379
Labeler code
0113
Product ID
0113-0379_5498661e-f533-495d-9699-483769c416d6
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
L. Perrigo Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1989-09-15
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
12.5 mg/5mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
good sense allergy
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1049906

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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26005090-31a1-441d-920b-db3101a55d53Product name320250221
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cb03406d-e223-80bb-67d8-be80f9b6a4f2Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0113-0379-262024-01-30C16284748780-11030e365-0d5a-111a-e063-dadaa90a10e2Perrigo Children’s Allergy Liquid Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0113-0379-26good sense allergy118 mL in 1 BOTTLESOLUTION1186
0113-0379-26good sense allergy1 in 1 CARTONSOLUTION16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0379GOOD SENSE ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [L. PERRIGO COMPANY]5Current NDC, Legacy NDC, 2 package rows20240712_bf5039a0-2109-41a2-84a9-b5167d0a93da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSNbf5039a0-2109-41a2-84a9-b5167d0a93da6
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCDbf5039a0-2109-41a2-84a9-b5167d0a93da6
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSYbf5039a0-2109-41a2-84a9-b5167d0a93da6
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSYbf5039a0-2109-41a2-84a9-b5167d0a93da6
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSYbf5039a0-2109-41a2-84a9-b5167d0a93da6
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilPSNbae7a52f-504b-416e-afdd-e6853e2d59445
212033aspirin 325 MG Oral TabletPSNbae7a52f-504b-416e-afdd-e6853e2d59445
211874BAYER Aspirin 325 MG Oral TabletPSNbae7a52f-504b-416e-afdd-e6853e2d59445
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSNbae7a52f-504b-416e-afdd-e6853e2d59445
1049633diphenhydrAMINE HCl 50 MG/ML Injectable SolutionPSNbae7a52f-504b-416e-afdd-e6853e2d59445
1870225EPINEPHrine (generic for Adrenaclick) 0.15 MG in 0.15 ML Auto-InjectorPSNbae7a52f-504b-416e-afdd-e6853e2d59445
1870230EPINEPHrine (generic for Adrenaclick) 0.3 MG in 0.3 ML Auto-InjectorPSNbae7a52f-504b-416e-afdd-e6853e2d59445
310519glucose 4 GM Chewable TabletPSNbae7a52f-504b-416e-afdd-e6853e2d59445
198039nitroglycerin 0.4 MG Sublingual TabletPSNbae7a52f-504b-416e-afdd-e6853e2d59445
211874aspirin 325 MG Oral Tablet [Bayer Aspirin]SBDbae7a52f-504b-416e-afdd-e6853e2d59445
212033aspirin 325 MG Oral TabletSCDbae7a52f-504b-416e-afdd-e6853e2d59445
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCDbae7a52f-504b-416e-afdd-e6853e2d59445
1049633diphenhydramine hydrochloride 50 MG/ML Injectable SolutionSCDbae7a52f-504b-416e-afdd-e6853e2d59445
310519glucose 4000 MG Chewable TabletSCDbae7a52f-504b-416e-afdd-e6853e2d59445
2123111NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCDbae7a52f-504b-416e-afdd-e6853e2d59445
1870225NDA020800 0.15 ML epinephrine 1 MG/ML Auto-InjectorSCDbae7a52f-504b-416e-afdd-e6853e2d59445
1870230NDA020800 0.3 ML epinephrine 1 MG/ML Auto-InjectorSCDbae7a52f-504b-416e-afdd-e6853e2d59445
198039nitroglycerin 0.4 MG Sublingual TabletSCDbae7a52f-504b-416e-afdd-e6853e2d59445
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilSYbae7a52f-504b-416e-afdd-e6853e2d59445
212033ASA 325 MG Oral TabletSYbae7a52f-504b-416e-afdd-e6853e2d59445
211874ASA 325 MG Oral Tablet [Bayer Aspirin]SYbae7a52f-504b-416e-afdd-e6853e2d59445
211874Bayer Aspirin 325 MG Oral TabletSYbae7a52f-504b-416e-afdd-e6853e2d59445
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSYbae7a52f-504b-416e-afdd-e6853e2d59445
1049633diphenhydramine HCl 50 MG/ML Injectable SolutionSYbae7a52f-504b-416e-afdd-e6853e2d59445
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSYbae7a52f-504b-416e-afdd-e6853e2d59445
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSYbae7a52f-504b-416e-afdd-e6853e2d59445
1870225epinephrine (generic for Adrenaclick) 0.15 MG per 0.15 ML Auto-InjectorSYbae7a52f-504b-416e-afdd-e6853e2d59445
1870230epinephrine (generic for Adrenaclick) 0.3 MG per 0.3 ML Auto-InjectorSYbae7a52f-504b-416e-afdd-e6853e2d59445
310519glucose 4 GM Chewable TabletSYbae7a52f-504b-416e-afdd-e6853e2d59445
198039nitroglycerin 400 MCG Sublingual TabletSYbae7a52f-504b-416e-afdd-e6853e2d59445
198039NTG 0.4 MG Sublingual TabletSYbae7a52f-504b-416e-afdd-e6853e2d59445
198039TNG 0.4 MG Sublingual TabletSYbae7a52f-504b-416e-afdd-e6853e2d59445
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN2861b801-e778-822d-e063-6394a90aa1a81
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD2861b801-e778-822d-e063-6394a90aa1a81
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY2861b801-e778-822d-e063-6394a90aa1a81
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY2861b801-e778-822d-e063-6394a90aa1a81
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY2861b801-e778-822d-e063-6394a90aa1a81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0379-26001130379261 BOTTLE in 1 CARTON (0113-0379-26) / 118 mL in 1 BOTTLE1 bottle1989-09-150000-00-00NoNoCurrent