FDA.reportPublic FDA data

NDC 0363-6080-01 - Medicated Lip Balm

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0363-6080
Requested NDC
0363-6080-01
Package NDCs from labels
0363-6080-01, 0363-6080-02
Manufacturer
Walgreen Co | Lee Pharmaceuticals
Effective date
2013-11-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Medicated Lip Balm - Walgreen Co | Lee PharmaceuticalsWalgreen Co | Lee Pharmaceuticals2013-11-15HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-6080-022019-11-27C16284748780-19855e2a2-32f1-60a7-e053-dbdaa90a05bdDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-6080-01Medicated Lip Balm4 g in 1 CONTAINERSTICK42
0363-6080-02Medicated Lip Balm2 in 1 BLISTER PACKSTICK22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-6080MEDICATED LIP BALM (MEDICATED LIP BALM STICK) STICK [WALGREEN CO]2Legacy NDC, 2 package rows20131115_0bb75602-7eb1-4d4a-9271-c7f84ff552f7.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAMPHOR (NATURAL)ACTIVE INGREDIENTN20HL7Q941MEDICATED LIP BALM (MEDICATED LIP BALM STICK) STICK [WALGREEN CO]2
MENTHOLACTIVE INGREDIENTL7T10EIP3AMEDICATED LIP BALM (MEDICATED LIP BALM STICK) STICK [WALGREEN CO]2
PHENOLACTIVE INGREDIENT339NCG44TVMEDICATED LIP BALM (MEDICATED LIP BALM STICK) STICK [WALGREEN CO]2
CAMPHOR (NATURAL)ACTIVE MOIETYN20HL7Q941MEDICATED LIP BALM (MEDICATED LIP BALM STICK) STICK [WALGREEN CO]2
MENTHOLACTIVE MOIETYL7T10EIP3AMEDICATED LIP BALM (MEDICATED LIP BALM STICK) STICK [WALGREEN CO]2
PHENOLACTIVE MOIETY339NCG44TVMEDICATED LIP BALM (MEDICATED LIP BALM STICK) STICK [WALGREEN CO]2
ALUM, POTASSIUMINACTIVE INGREDIENT1L24V9R23SMEDICATED LIP BALM (MEDICATED LIP BALM STICK) STICK [WALGREEN CO]2
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRRMEDICATED LIP BALM (MEDICATED LIP BALM STICK) STICK [WALGREEN CO]2
LANOLININACTIVE INGREDIENT7EV65EAW6HMEDICATED LIP BALM (MEDICATED LIP BALM STICK) STICK [WALGREEN CO]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UMEDICATED LIP BALM (MEDICATED LIP BALM STICK) STICK [WALGREEN CO]2
SALICYLIC ACIDINACTIVE INGREDIENTO414PZ4LPZMEDICATED LIP BALM (MEDICATED LIP BALM STICK) STICK [WALGREEN CO]2
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FMEDICATED LIP BALM (MEDICATED LIP BALM STICK) STICK [WALGREEN CO]2

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 5 of 224 · 4,472 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INVISIBLE ACNE PATCHESSALICYLIC ACID 0.5%Global America Group LLC1527e15f-472f-4e05-adb6-c2e561f503cf2026-08-31WarningsExact identifier
unii: O414PZ4LPZ
Orajel 4X Medicated Toothache and Gum CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1c82b4-02b3-d456-e063-6294a90a16bb2026-08-31WarningsExact identifier
unii: L7T10EIP3A
Orajel 4X Medicated Toothache and Gum PM CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1cdaf4-3388-280c-e063-6294a90ac70f2026-08-31WarningsExact identifier
unii: L7T10EIP3A
REINREUDE SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a539219-f9b8-5e94-e063-6294a90a25932026-08-31WarningsExact identifier
unii: L7T10EIP3A
SERYNTH SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a5405f9-9881-e547-e063-6294a90a0d102026-08-31WarningsExact identifier
unii: L7T10EIP3A
PURE PETROLATUMPETROLATUMVASA COSMETICS PRIVATE LIMITED5a57b197-3e18-b3ab-e063-6394a90aed822026-08-31WarningsExact identifier
unii: 4T6H12BN9U
OLNUITEXL WART REMOVERSALICYIC ACIDGuangzhou ChuanMa International Trading Co.,Ltd.5a41ed8c-8fdb-1c8c-e063-6394a90afd4d2026-08-30WarningsExact identifier
unii: O414PZ4LPZ
EAYONYUMT NECK PAIN RELIEFMENTHOLWuhan Ruihengjie Technology Co., Ltd.5a450e68-07a7-a4bb-e063-6294a90a97c92026-08-30WarningsExact identifier
unii: L7T10EIP3A
EAYONYUM BACK PAIN RELIEVINGMENTHOLWuhan Ruihengjie Technology Co., Ltd.5a458280-4f9c-5af6-e063-6394a90acb2e2026-08-30WarningsExact identifier
unii: L7T10EIP3A
EAYONYUM KNEE PAIN RELIEVINGMENTHOLWuhan Ruihengjie Technology Co., Ltd.5a45d19f-c753-71eb-e063-6294a90a48052026-08-30WarningsExact identifier
unii: L7T10EIP3A
The Acne Spot TreatmentSALICYLIC ACID SPOTSpotless, Inc.4a1a3716-9eaf-6be4-e063-6294a90a31c32026-08-30WarningsExact identifier
unii: O414PZ4LPZ
SYLVIRENE SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a4fd689-2113-f15a-e063-6394a90a45ad2026-08-30WarningsExact identifier
unii: L7T10EIP3A
Rhinoost SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a296baa-c101-3192-e063-6394a90aa2b02026-08-29WarningsExact identifier
unii: L7T10EIP3A
LUCKSKY SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a29ee19-8b6d-b4fa-e063-6394a90ad81d2026-08-29WarningsExact identifier
unii: L7T10EIP3A
Flobow SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a2aa169-90b5-417f-e063-6394a90aa2782026-08-29WarningsExact identifier
unii: L7T10EIP3A
Orraya WART REMOVER LiquidSALICYLIC ACID 40% WART REMOVER LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.5a2cf1de-789c-04b0-e063-6394a90ac59e2026-08-29WarningsExact identifier
unii: O414PZ4LPZ
Olu Pain ManagementLIDOCAINE AND CAMPHORHAWAII REPACK, INC.31ed3d82-ba12-46b2-b0ec-7e5e019efc102026-08-28WarningsExact identifier
unii: N20HL7Q941
Hoxlbin SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a17b116-d573-1c4a-e063-6394a90a499b2026-08-28WarningsExact identifier
unii: L7T10EIP3A
Orajel 4X Medicated Toothache and GumBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1b4133-0eac-2f8f-e063-6394a90af8f62026-08-28WarningsExact identifier
unii: L7T10EIP3A
HYDROPHORHYDROPHORAkron Pharma Inc.e6099df7-d418-479a-9d2e-ced523585aed2026-08-28WarningsExact identifier
unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.