FDA.reportPublic FDA data

NDC 61941-0122-1 - Organix Complete

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
61941-0122
Requested NDC
61941-0122-1
Package NDCs from labels
61941-0122-1, 61941-0122-2
Manufacturer
ProPhase Labs, Inc. | Pharmaloz Manufacturing, Inc.
Effective date
2011-04-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ORganix™ COMPLETE Cough & Sore Throat Drops Honey LemonProPhase Labs, Inc. | Pharmaloz Manufacturing, Inc.2011-04-06HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61941-0122-22020-01-31C16284748780-19d75b9d1-06ed-f424-e053-dadaa90a57ceORganix™ COMPLETE Cough & Sore Throat Drops Honey Lemon

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61941-0122-1Organix Complete21 in 1 PACKAGELOZENGE211
61941-0122-2Organix Complete48 in 1 CASELOZENGE481

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61941-0122ORGANIX COMPLETE (MENTHOL AND PECTIN) LOZENGE [PROPHASE LABS, INC.]1Legacy NDC, 2 package rows20110601_8c4944e0-d005-41c0-80d6-17f4951ebefc.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MentholACTIVE INGREDIENTL7T10EIP3AORGANIX COMPLETE (MENTHOL AND PECTIN) LOZENGE [PROPHASE LABS, INC.]1
PectinACTIVE INGREDIENT89NA02M4RXORGANIX COMPLETE (MENTHOL AND PECTIN) LOZENGE [PROPHASE LABS, INC.]1
MentholACTIVE MOIETYL7T10EIP3AORGANIX COMPLETE (MENTHOL AND PECTIN) LOZENGE [PROPHASE LABS, INC.]1
PectinACTIVE MOIETY89NA02M4RXORGANIX COMPLETE (MENTHOL AND PECTIN) LOZENGE [PROPHASE LABS, INC.]1
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPORGANIX COMPLETE (MENTHOL AND PECTIN) LOZENGE [PROPHASE LABS, INC.]1
ElmINACTIVE INGREDIENT63POE2M46YORGANIX COMPLETE (MENTHOL AND PECTIN) LOZENGE [PROPHASE LABS, INC.]1
Eucalyptus OilINACTIVE INGREDIENT2R04ONI662ORGANIX COMPLETE (MENTHOL AND PECTIN) LOZENGE [PROPHASE LABS, INC.]1
HoneyINACTIVE INGREDIENTY9H1V576FHORGANIX COMPLETE (MENTHOL AND PECTIN) LOZENGE [PROPHASE LABS, INC.]1
HyssopINACTIVE INGREDIENTX7HKN4FOJIORGANIX COMPLETE (MENTHOL AND PECTIN) LOZENGE [PROPHASE LABS, INC.]1
Lemon OilINACTIVE INGREDIENTI9GRO824LLORGANIX COMPLETE (MENTHOL AND PECTIN) LOZENGE [PROPHASE LABS, INC.]1
Peppermint OilINACTIVE INGREDIENTAV092KU4JHORGANIX COMPLETE (MENTHOL AND PECTIN) LOZENGE [PROPHASE LABS, INC.]1
SageINACTIVE INGREDIENT065C5D077JORGANIX COMPLETE (MENTHOL AND PECTIN) LOZENGE [PROPHASE LABS, INC.]1
SucroseINACTIVE INGREDIENTC151H8M554ORGANIX COMPLETE (MENTHOL AND PECTIN) LOZENGE [PROPHASE LABS, INC.]1
Sunflower OilINACTIVE INGREDIENT3W1JG795YIORGANIX COMPLETE (MENTHOL AND PECTIN) LOZENGE [PROPHASE LABS, INC.]1
ThymeINACTIVE INGREDIENTCW657OBU4NORGANIX COMPLETE (MENTHOL AND PECTIN) LOZENGE [PROPHASE LABS, INC.]1

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 1 of 123 · 2,444 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWALMART INC. (see also Equate)9a9c5c6b-94fe-484a-a879-12c29cbdefe42026-09-11WarningsExact identifier
unii: L7T10EIP3A
OTTFFSS SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5b0991b6-59cc-59b3-e063-6394a90a76932026-09-09WarningsExact identifier
unii: L7T10EIP3A
THITFAM SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a78d096-4740-8dd4-e063-6294a90a651f2026-09-09WarningsExact identifier
unii: L7T10EIP3A
Magic CreamPAIN RELIEVING OINTMENTJiangxi Baikang Medical Products Co., Ltd.5b0f2515-47e9-603f-e063-6294a90af9d42026-09-09WarningsExact identifier
unii: L7T10EIP3A
Nerve Guard Nerve ReliefLIDOCAINE HYDROCHLORIDE, MENTHOL,MAGNESIUM CHLORIDEMicelle Laboratories, Incorporated6b78f40f-2a7f-4c49-96af-1a95acbf430f2026-09-04WarningsExact identifier
unii: L7T10EIP3A
Equate Menthol Pain RelievingMENTHOLWal-Mart Stores Incd5b0a7f1-4e23-426b-bb7e-aaa251ad4ffc2026-09-03WarningsExact identifier
unii: L7T10EIP3A
ZHI TechnologiesLIDOCAINE, MENTHOLZHI Technologies, Inc.6717e995-4d2d-49e8-8ecf-7c62557dfdef2026-09-03WarningsExact identifier
unii: L7T10EIP3A
FREEZE EASE Roll-OnMENTHOLGlobal America Group LLC1869cc0d-a056-45de-aede-23b09b61ed122026-09-02WarningsExact identifier
unii: L7T10EIP3A
Gaimoa Lidocaine Pain Relief Gel PatchesLIDOCAINE PAIN RELIEF GEL PATCHESHenan Enokon Medical Instrument Co., Ltd.5a68fe67-5c15-af9a-e063-6294a90a7ec12026-09-01WarningsExact identifier
unii: L7T10EIP3A
Ramedica Herbal Wonder BalmCAMPHOR, MENTHOLRamedicare Sdn. Bhd.cfb2ea0e-a1f6-4fdf-b866-346bbe78788f2026-09-01WarningsExact identifier
unii: L7T10EIP3A
La Vaquita New RegularMETHYL SALICYLATEDelon Laboratories (1990) Ltdd62186ac-afbb-443e-98c2-f0d122422a3c2026-09-01WarningsExact identifier
unii: L7T10EIP3A
ActivICEMENTHOLMedline Industries, LP834adeb9-38ad-0cfe-e053-2991aa0af82f2026-09-01WarningsExact identifier
unii: L7T10EIP3A
La Vaquita New ExtraMETHYL SALICYLATE, MENTHOLDelon Laboratories (1990) Ltd3097a01b-cee5-492f-b65a-63992fb28e3a2026-09-01WarningsExact identifier
unii: L7T10EIP3A
MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH SUGAR FREEHEXYLRESORCINOL AND MENTHOLReckitt Benckiser LLC4a938e15-a996-8538-e063-6294a90ad4ee2026-09-01WarningsExact identifier
unii: L7T10EIP3A
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWALMART INC. (see also Equate)ceb125d9-8c1b-498c-b0f0-f18756ede4422026-09-01WarningsExact identifier
unii: L7T10EIP3A
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
EAYONYUMT NECK PAIN RELIEFMENTHOLWuhan Ruihengjie Technology Co., Ltd.5a450e68-07a7-a4bb-e063-6294a90a97c92026-08-30WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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