FDA.reportPublic FDA data

NDC 70677-1019-01 - Pseudoephedrine hydrochloride

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
70677-1019
Requested NDC
70677-1019-01
Package NDCs from labels
70677-1019-1, 70677-1019-2, 70677-1019-01
Manufacturer
STRATEGIC SOURCING SERVICES LLC | Ohm Laboratories Inc.
Effective date
2026-10-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Pseudoephedrine hydrochloride 120 mg 12 Hour Extended-Release Tablets, USPSTRATEGIC SOURCING SERVICES LLC | Ohm Laboratories Inc.2026-10-09HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1019-1Pseudoephedrine hydrochloride1 in 1 CARTONTABLET, FILM COATED12
70677-1019-1Pseudoephedrine hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED102
70677-1019-2Pseudoephedrine hydrochloride2 in 1 CARTONTABLET, FILM COATED22
70677-1019-2Pseudoephedrine hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1019PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED [STRATEGIC SOURCING SERVICES LLC]1Current NDC, 4 package rows20230815_3bf95c58-4fd9-4caa-a54f-2e61a5eacae8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1019-1EA - Each70677-10199c16ed02-80c3-41d8-b7ff-be3f73400bfd12024-01-04
70677-1019-2EA - Each70677-1019771a37df-376d-47e5-9d8c-bf2b52730d3712026-05-22

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 89 of 144 · 2,870 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TiZO Mineral Sun Defense SPF 50TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.2cc8f7ef-eda3-fe71-e063-6394a90a6a9a2025-01-28WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEZ&Z Skin Essentials2cdc48f3-474f-9c06-e063-6294a90afea12025-01-27WarningsExact identifier
unii: 15FIX9V2JP
Cetaphil Sheer Mineral Sunscreen Stick SPF 50TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.54f6df65-e90c-4070-aa95-f47496dd11bd2025-01-27WarningsExact identifier
unii: 15FIX9V2JP
Bestmade Natural Products BM55DAPHNE INDICA, NATRUM PHOS, SILICA MARINA, TABACUMBestmade Natural Products2c751942-5b36-8558-e063-6294a90af87a2025-01-24WarningsExact identifier
unii: ETJ7Z6XBU4
ConstipationECHINACEA, IRIS VERSICOLOR, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ABIES NIGRA, AESCULUS HIPPOCASTANUM, ALOE, ALUMINA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLLINSONIA CANADENSIS, GRAPHITE, HYDRASTIS CANADENSIS 15X, KALI CARBONICUM 15X, LYCOPODIUM CLAVATUM 15X, MAGNESIA MURIATICA 15X, MEZEREUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHAMNUS PURSHIANA, SANICULA, SELENIUM METALLICUM, SEPIA, SILICEA, TABACUM, VERATRUM ALBUM, ZINCUM METALLICUMNewton Laboratories, Inc.9d626292-7abb-1afb-e053-2995a90a28182025-01-24WarningsExact identifier
unii: ETJ7Z6XBU4
CoTZ Silky Foam - TintedTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTDd63088d7-a1d7-4b56-a7d8-ad217011a8a82025-01-24WarningsExact identifier
unii: 15FIX9V2JP
CoTZ Silky Foam Non-TintedTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD9c04b76e-ae65-4183-b475-3b8e8764db592025-01-24WarningsExact identifier
unii: 15FIX9V2JP
DOCTRUST K ToothSILICON DIOXIDE, SODIUM MONOFLUOROPHOSPHATEDOCSMEDI Co., Ltd.a02f8865-e7be-4ef4-b09c-dad8466397642025-01-22WarningsExact identifier
unii: ETJ7Z6XBU4
Lemon QuinceLEMON QUINCEUriel Pharmacy Inc332e4a40-e0f3-11de-8a39-0800200c9a662025-01-22WarningsExact identifier
unii: ETJ7Z6XBU4
Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and HeadacheNAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDEAurohealth LLC10a8a74b-11d1-490e-87e7-d705fe0e76022025-01-21WarningsExact identifier
unii: 6V9V2RYJ8N
Proceuticals Private Label by TiZO Tinted Facial Mineral Sunscreen BackbarTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD2be9f92a-a041-0595-e063-6394a90af7a82025-01-17WarningsExact identifier
unii: 15FIX9V2JP
Hydration ComplexBETA VULGARIS, BOLDO, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CARDUUS BENEDICTUS, CHELIDONIUM MAJUS, COFFEA TOSTA, EQUISETUM ARVENSE, GERMANIUM SESQUIOXIDE, GINKGO BILOBA, HYPERICUM PERFORATUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, PETROSELINUM SATIVUM, SILICEA, TARAXACUM OFFICINALEDeseret Biologicals, Inc.f60a2ab8-4146-4995-9bc6-be2660b175402025-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
HUTTON KLEIN HK DERMATOLOGISTS SPF 40 Mineral Based Facial Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEHutton, Kathleen MD293a6a6c-adf3-452d-92f5-3baceb619e392025-01-16WarningsExact identifier
unii: 15FIX9V2JP
CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 020OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEParfums Christian Dior594982d5-b4bf-4889-99b7-b3cd58fa80312025-01-16WarningsExact identifier
unii: 15FIX9V2JP
CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 010OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEParfums Christian Dior26f1dcde-209e-4c6d-9577-1f3d3e21595f2025-01-16WarningsExact identifier
unii: 15FIX9V2JP
CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 000OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEParfums Christian Dioradba288c-e94f-4b26-8f7d-336f3e5108bd2025-01-16WarningsExact identifier
unii: 15FIX9V2JP
SUNSTATION USA SPF-30 SPORT SUNSCREEN-SUNSTATION USA SPF-30 SPORT SUNSCREEN-Sunstation USA, LLC2bd84b92-dcf0-404f-e063-6294a90a10602025-01-16Exact identifier
unii: 15FIX9V2JP
Emme Diane Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEEmme Diane, Incab53ad98-b667-4447-8177-724dbf771e802025-01-16WarningsExact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEHutton, Kathleen MD2be51fdf-c3f2-463b-8c7d-bda07db17e1b2025-01-16WarningsExact identifier
unii: 15FIX9V2JP
Stay AgelessTinted Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDESpectrum Aesthetics Laser Training LLC026b9b30-ef08-bf2e-e063-6394a90a54a62025-01-14WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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