NDC 53209-2001-01 - Motrin IB

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
53209-2001
Requested NDC
53209-2001-01
Package NDCs from labels
53209-2001-1, 53209-2001-2, 53209-2001-01
Manufacturer
Morning Star OTC
Effective date
2025-06-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Motrin IB - Morning Star OTCMorning Star OTC2025-06-19HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53209-2001-1Motrin IB2 in 1 BLISTER PACKTABLET, FILM COATED21
53209-2001-2Motrin IB25 in 1 POUCHTABLET, FILM COATED251

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 185 of 191 · 3,812 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GUNA BOWEL PLUSACTIVATED CHARCOAL - ALOE - ALUMINUM OXIDE - BRYONIA ALBA ROOT - CHELIDONIUM MAJUS - COLLINSONIA - FRANGULA ALNUS BARK - LYCOPODIUM CLAVATUM SPORE - POTASSIUM CARBONATE- RHUBARB - STRYCHNOS NUX VOMICA SEED - SILYBUM MARIANUM SEED - SKATOLE - SODIUM CARBONATE - SUS SCROFA PANCREAS - TARAXACUM OFFICINALE - THIAMINE -Guna spab3aa4fd3-c87a-ccd2-e053-2995a90a46a92021-01-17WarningsExact identifier
unii: LMI26O6933
ibuprofenIBUPROFENProficient Rx LP924d2dd0-3b7d-42ec-b617-86729dba2b952021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENProficient Rx LPe23eb275-ce0c-40ec-b809-a48c5e46c7ec2021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Post - VaccinationINFLUENZINUM, MORBILLINUM, PERTUSSINUM, ACONITUM NAP., ALUMINA, ANTIMON. TART., ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CINCHONA, CROTALUS HORRIDUS, GELSEMIUM, KALI BIC., LACHESIS, LEDUM, MERC. VIV., MEZEREUM, NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SILICEA, SULPHUR, THUJA OCC., VACCINIUM, APIS MEL., ECHINACEA, HYPERICUMNewton Laboratories, Inc.997474d5-4dc4-6104-e053-2995a90a03f12020-12-07WarningsExact identifier
unii: LMI26O6933
unii: ETJ7Z6XBU4
Oral Care-GingivitisACONITUM NAP., ARNICA, ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CALENDULA, CHAMOMILLA, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, GELSEMIUM, HEPAR SULPH. CALC., KREOSOTUM, MERC. VIV., MYRRHA, NUX VOM., PHOSPHORUS, PHYTOLACCA, PLANTAGO, RHUS TOXICODENDRON, SILICEA, STAPHYSAG., ECHINACEANewton Laboratories, Inc.9971a7f4-c02c-02ba-e053-2a95a90a2b732020-12-04WarningsExact identifier
unii: ETJ7Z6XBU4
Female FemroidsHYDRASTIS CANADENSIS, THUJA OCCIDENTALIS, ARSENICUM ALBUM, CALCAREA IODATA, CARBO ANIMALIS, CONIUM MACULATUM, GRAPHITES, HYDRASTIS CANADENSIS, IODIUM, KREOSOTUM, LACHESIS MUTUS, PHOSPHORUS, SABINA, SECALE CORNUTUM, SEPIA, SILICEA, THLASPI BURSA-PASTORIS, THUJA OCCIDENTALIS, THYROIDINUM, TRILLIUM PENDULUM, USTILAGO MAIDIS.Newton Laboratories, Inc.9a01acb9-1b2b-3a33-e053-2995a90adc922020-12-03WarningsExact identifier
unii: ETJ7Z6XBU4
FungalCANDIDA ALBICANS, SANICULA, TELLURIUM METALLICUM, TORULA CEREVISIAE, ANTIMON. CRUD., ARSENICUM ALB., BARYTA CARB., BRYONIA, CALC. CARB., CARBO VEG., CUPRUM MET., DULCAMARA, GRAPHITES, KALI CARB., LACHESIS, LYCOPODIUM, MEZEREUM, NITRICUM AC., PHOSPHORUS, PHYTOLACCA, SEPIA, SILICEA, SULPHUR, SULPHURICUM AC., ZINC. MET., APIS MEL., THUJA OCC.Newton Laboratories, Inc.99487f4a-76f6-407b-e053-2a95a90acfd42020-12-03WarningsExact identifier
unii: ETJ7Z6XBU4
Thyroid-AdrenalADRENALINUM, THYROIDINUM, ALOE, CALC. CARB., CHELIDONIUM MAJUS, CONIUM, GRAPHITES, IODIUM, LACHESIS, LYCOPODIUM, LYCOPUS VIRGINICUS, PHYTOLACCA, RHUS TOXICODENDRON, SILICEA, SPONGIA, ECHINACEANewton Laboratories, Inc.b59731a2-c775-7e8a-e053-2a95a90a90622020-12-03WarningsExact identifier
unii: ETJ7Z6XBU4
Acne - Cystic AcneECHINACEA, JUGLANS REGIA, LAPPA MAJOR, TARAXACUM OFFICINALE, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, AURUM METALLICUM, BERBERIS AQUIFOLIUM, BOVISTA, CARBO VEGETABILIS, CAUSTICUM, CHELIDONIUM MAJUS, DULCAMARA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, HYDROCOTYLE ASIATICA, KALI BROMATUM, KALI IODATUM, LEDUM PALUSTRE, LYCOPDIUM CLAVATUM, NUX VOMICA, SULPHUR IODATUM, ZINCUM METALLICUM, SILICEANewton Laboratories, Inc92afe017-74c7-16c6-e053-2995a90a5c7d2020-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
Breast Care - FibrocysticBUFO RANA, APIS MEL., ASTERIAS RUBENS, BELLADONNA, BRYONIA, CALC. CARB., CHAMOMILLA, CHIMAPHILA UMBELLATA, CINCHONA, CONIUM, CROTON, ECHINACEA, GRAPHITES, HELONIAS DIOICA, LACHESIS, MERC. VIV., PHELLANDRIUM AQUATICUM PHOSPHORUS, PHYTOLACCA, PULSATILLA, SANGUINARIA, SILICEA, HAMAMELIS, RUTA, TARAXACUMNewton Laboratories, Inc.98d01128-9887-12ce-e053-2a95a90a73292020-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
IbuprofenIBUPROFENProficient Rx LP8813a8a4-ebbd-4204-88a3-600a92ea91702020-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Thyroid-AdrenalADRENALINUM, THYROIDINUM, ALOE, CALC. CARB., CHELIDONIUM MAJUS, CONIUM, GRAPHITES, IODIUM, LACHESIS, LYCOPODIUM, LYCOPUS VIRGINICUS, PHYTOLACCA, RHUS TOXICODENDRON, SILICEA, SPONGIA, ECHINACEANewton Laboratories, Inc.b56f2ffc-4637-1f23-e053-2a95a90aa3af2020-12-01WarningsExact identifier
unii: ETJ7Z6XBU4
Hair-ScalpAPIS MEL., ARSENICUM ALB., CALC. CARB., DULCAMARA, GRAPHITES, HEPAR SULPH. CALC., HYDRASTIS, HYDROFLUORICUM ACIDUM, KALI CARB., LYCOPODIUM, MEZEREUM, OLEANDER, PETROLEUM, PHOSPHORICUM AC., PHOSPHORUS, RHUS TOXICODENDRON, SELENIUM, SEPIA, SILICEA, SULPHUR, THUJA OCC.Newton Laboratories, Inc.9ab3b944-443c-74a1-e053-2a95a90aa0e52020-11-30WarningsExact identifier
unii: ETJ7Z6XBU4
AcneANTIMON. CRUD., ARSENICUM ALB., AUR. MET., BERBER. AQUI., BOVISTA, CARBO VEG., CAUSTICUM, CHELIDONIUM MAJUS, DULCAMARA, GRAPHITES, HEPAR SULPH. CALC., HYDROCOTYLE, KALI BROM., KALI IOD., LEDUM, LYCOPODIUM, NUX VOM., SILICEA, SULPHUR IOD., ZINC. MET., ECHINACEA, JUGLANS REGIA, LAPPA, TARAXACUMNewton Laboratories, Inc.798c853c-16ab-8502-e053-2a91aa0a65322020-11-24WarningsExact identifier
unii: ETJ7Z6XBU4
AcneANTIMON. CRUD., ARSENICUM ALB., AUR. MET., BERBER. AQUI., BOVISTA, CARBO VEG., CAUSTICUM, CHELIDONIUM MAJUS, DULCAMARA, GRAPHITES, HEPAR SULPH. CALC., HYDROCOTYLE, KALI BROM., KALI IOD., LEDUM, LYCOPODIUM, NUX VOM., SILICEA, SULPHUR IOD., ZINC. MET., ECHINACEA, JUGLANS REGIA, LAPPA, TARAXACUMNewton Laboratories, Inc.798d5f34-819a-9895-e053-2991aa0a1d622020-11-24WarningsExact identifier
unii: ETJ7Z6XBU4
Breast CareBUFO RANA, APIS MEL., ASTERIAS RUBENS, BELLADONNA, BRYONIA, CALC. CARB., CHAMOMILLA, CHIMAPHILA UMBELLATA, CINCHONA, CONIUM, CROTON, ECHINACEA, GRAPHITES, HELONIAS DIOICA, LACHESIS, MERC. VIV., PHELLANDRIUM AQUATICUM PHOSPHORUS, PHYTOLACCA, PULSATILLA, SANGUINARIA, SILICEA, HAMAMELIS, RUTA, TARAXACUMNewton Laboratories, Inc.79edde91-f909-f7b3-e053-2991aa0a9d1c2020-11-24WarningsExact identifier
unii: ETJ7Z6XBU4
ConstipationABIES NIG., AESCULUS HIPP., ALOE, ALUMINA, BRYONIA, CARBO VEG., CHELIDONIUM MAJUS, COLLINSONIA , GRAPHITES, HYDRASTIS, KALI CARB., LYCOPODIUM, MAG. MUR., MEZEREUM, NUX VOM., PODOPH. PELT., RHAMNUS PURSHIANA, SANICULA, SELENIUM, SEPIA, SILICEA, TABACUM, VERATRUM ALB., ZINC.MET., ECHINACEA, IRIS VERSICOLOR, PHYTOLACCA, TARAXACUMNewton Laboratories, Inc.90807700-3099-850c-e053-2995a90ada552020-11-24WarningsExact identifier
unii: LMI26O6933
unii: ETJ7Z6XBU4
ConstipationABIES NIG., AESCULUS HIPP., ALOE, ALUMINA, BRYONIA, CARBO VEG., CHELIDONIUM MAJUS, COLLINSONIA , GRAPHITES, HYDRASTIS, KALI CARB., LYCOPODIUM, MAG. MUR., MEZEREUM, NUX VOM., PODOPH. PELT., RHAMNUS PURSHIANA, SANICULA, SELENIUM, SEPIA, SILICEA, TABACUM, VERATRUM ALB., ZINC.MET., ECHINACEA, IRIS VERSICOLOR, PHYTOLACCA, TARAXACUMNewton Laboratories, Inc.90804a94-1e67-3ab3-e053-2a95a90aafbe2020-11-24WarningsExact identifier
unii: LMI26O6933
unii: ETJ7Z6XBU4
Post - VaccinationINFLUENZINUM, MORBILLINUM, PERTUSSINUM, ACONITUM NAP., ALUMINA, ANTIMON. TART., ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CINCHONA, CROTALUS HORRIDUS, GELSEMIUM, KALI BIC., LACHESIS, LEDUM, MERC. VIV., MEZEREUM, NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SILICEA, SULPHUR, THUJA OCC., VACCINIUM, APIS MEL., ECHINACEA, HYPERICUMNewton Laboratories, Inc.9042b7ad-15ed-0e81-e053-2a95a90afe282020-11-23WarningsExact identifier
unii: LMI26O6933
unii: ETJ7Z6XBU4
Post-VaccinationINFLUENZINUM, MORBILLINUM, PERTUSSINUM, ACONITUM NAP., ALUMINA, ANTIMON. TART., ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CINCHONA, CROTALUS HORRIDUS, GELSEMIUM, KALI BIC., LACHESIS, LEDUM, MERC. VIV., MEZEREUM, NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SILICEA, SULPHUR, THUJA OCC., VACCINIUM, APIS MEL., ECHINACEA, HYPERICUMNewton Laboratories, Inc.90bb15e5-3d9d-e2e2-e053-2995a90a85ac2020-11-23WarningsExact identifier
unii: LMI26O6933
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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