Giant Eagle Original Antiseptic

Product NDC
63148-018
11-digit product format
631480018
Labeler code
63148
Product ID
63148-018_212cb790-3cfd-4cb3-89ca-5d3d2e30e2c3
Type
HUMAN OTC DRUG
Nonproprietary name
Eucalyptol, Menthol, Methyl Salicylate, Thymol
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Apollo Health and Beauty Care Inc.
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2019-09-11
Marketing end
0000-00-00
Substance
EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL
Active strength
1 mg/mL; mg/mL; mg/mL; mg/mL
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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63148-018-332021-01-29C16284748780-1ba0f9c33-32a9-a910-e053-dadaa90a0b85Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63148-018-33Giant Eagle Original Antiseptic1000 mL in 1 BOTTLE, PLASTICMOUTHWASH10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63148-018GIANT EAGLE ORIGINAL ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [APOLLO HEALTH AND BEAUTY CARE INC.]1Legacy NDC, 1 package rows20190913_071b5bf5-736c-4f0f-98cc-5c4b93902a60.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashPSN071b5bf5-736c-4f0f-98cc-5c4b93902a601
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD071b5bf5-736c-4f0f-98cc-5c4b93902a601
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY071b5bf5-736c-4f0f-98cc-5c4b93902a601

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
63148-018-33631480018331000 mL in 1 BOTTLE, PLASTIC1000 mlHistorical