NDC 11523-4331-01 - Claritin
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
- 11523-4331
- Requested NDC
- 11523-4331-01
- Package NDCs from labels
- 11523-4331-1, 11523-4331-2, 11523-4331-6, 11523-4331-01
- Manufacturer
- Bayer HealthCare LLC. | Patheon Manufacturing Services LLC
- Effective date
- 2025-12-05
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Claritin - Bayer HealthCare LLC. | Patheon Manufacturing Services LLC | Bayer HealthCare LLC. | Patheon Manufacturing Services LLC | 2025-12-05 | HUMAN OTC DRUG LABEL |
| Children's Claritin ® Chewables 5mg Grape & Bubblegum UIs 1611948 & 1612741 | Bayer HealthCare LLC. | 2025-12-04 | HUMAN OTC DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11523-4331-1 | Claritin | 10 in 1 BLISTER PACK | TABLET, CHEWABLE | 10 | 14 | |
| 11523-4331-1 | Claritin | 4 in 1 CARTON | TABLET, CHEWABLE | 4 | 14 | |
| 11523-4331-2 | Claritin | 10 in 1 BLISTER PACK | TABLET, CHEWABLE | 10 | 14 | |
| 11523-4331-2 | Claritin | 6 in 1 CARTON | TABLET, CHEWABLE | 6 | 14 | |
| 11523-4331-6 | Claritin | 8 in 1 CARTON | TABLET, CHEWABLE | 8 | 14 | |
| 11523-4331-6 | Claritin | 10 in 1 BLISTER PACK | TABLET, CHEWABLE | 10 | 14 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 11523-4331 | CLARITIN (LORATADINE) TABLET, CHEWABLE [BAYER HEALTHCARE LLC.] | 13 | Current NDC, Legacy NDC, 6 package rows | 20230629_37732ca2-b454-4215-91a2-c62e0f7a56af.zip |
DailyMed Socrata Ingredients#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Metab | CALCAREA SULPHURICA, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, CEREBELLUM (SUIS), GALLBLADDER (BOVINE), HEART (BOVINE), HEPAR (BOVINE), HYPOTHALAMUS SUIS, INTESTINE (SUIS), KIDNEY (BOVINE), LUNG (BOVINE), MEDULLA OSSIS SUIS, PANCREAS SUIS, PINEAL GLAND (SUIS), RECTAL MUCOSA (SUIS), SPLEEN (BOVINE), STOMACH (SUIS), THYMUS (OVINE), THYROIDINUM (BOVINE), URINARY BLADDER (SUIS), PITUITARUM POSTERIUM (BOVINE), ACETYL COENZYME A, | Nutritional Specialties, Inc. | bbed9973-238f-47c5-9a50-ac0869a7eb3a | 2023-10-09 | Warnings | ETJ7Z6XBU4 XF417D3PSL |
| BHI Migraine | ACETIC ACID, ARANEUS DIADEMATUS, ASAFETIDA, BRYONIA ALBA WHOLE, TRIBASIC CALCIUM PHOSPHATE, ACTIVATED CHARCOAL, CINCHONA OFFICINALIS BARK, MARSDENIA CONDURANGO BARK, TUBOCURARINE CHLORIDE, KALMIA LATIFOLIA LEAF, LYCOPODIUM CLAVATUM SPORE, SODIUM SULFATE, PHOSPHORIC ACID, PULSATILLA VULGARIS, CLAVICEPS PURPUREA SCLEROTIUM, AND SILICON DIOXIDE | MediNatura Inc | 11cad8ba-6914-420e-bab0-4ca37d33f2e6 | 2023-09-28 | Warnings | ETJ7Z6XBU4 |
| Zeel | ALPHA LIPOIC ACID, ARNICA MONTANA WHOLE,SUS SCROFA CARTILAGE, COENZYME A,SOLANUM DULCAMARA TOP,SUS SCROFA EMBRYO,SUS SCROFA UMBILICAL CORD, NADIDE, SODIUM DIETHYL OXALACETATE,SUS SCROFA PLACENTA,TOXICODENDRON PUBESCENS LEAF, SANGUINARIA CANADENSIS ROOT, SILICON DIOXIDE,SULFUR,CORIANDER | Biologische Heilmittel Heel | d5d7a2e5-a6ce-4a41-9430-1378023aa7d0 | 2023-09-28 | Warnings | ETJ7Z6XBU4 |
| Loratadine | LORATADINE ORAL | Better Living Brands LLC | f7dc7a3d-6709-d7e7-e053-6394a90acde8 | 2023-09-26 | Warnings | 7AJO3BO7QN |
| Loratadine ODT | LORATADINE | Better Living Brands, LLC | fad93257-bfcf-5e04-e053-6394a90a10a6 | 2023-09-25 | Warnings | 7AJO3BO7QN |
| Stomach Distress | BISMUTHUM SUBNITRICUM, CALCAREA SULPHURICA, CARBO ANIMALIS, CARBO VEGETABILIS, CINCHONA OFFICINALIS, HYDRASTIS CANADENSIS, NUX VOMICA, ORNITHOGALUM UMBELLATUM, PYROGENIUM, SILICEA, | Liddell Laboratories, Inc. | 4c764fbe-2fbf-4f06-9ad5-824373c6929a | 2023-09-11 | Warnings | ETJ7Z6XBU4 |
| Loratadine | LORATADINE | Camber Consumer Care Inc | d57da4bd-af37-414a-a50c-e80d2bb28314 | 2023-09-08 | Warnings | 7AJO3BO7QN |
| AnubisMed | SPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSION | ANUBIS COSMETICS SL | e99d92c4-8768-9c0a-e053-2a95a90a609e | 2023-09-05 | Warnings | ETJ7Z6XBU4 XF417D3PSL |
| MEB Puri-vega | MEB PURI-VEGA | Kadesh Incoporation Co,Ltd | 03865989-3034-10fc-e063-6394a90ac80b | 2023-09-05 | Warnings | ETJ7Z6XBU4 |
| Lipotox | SQUALENE, CHOLESTERINUM, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, | BioActive Nutritional, Inc. | a1538692-ca00-4e52-9b7e-409767ee27e1 | 2023-09-05 | Warnings | Z0H242BBR1 |
| Anubis Barcelona Protective Line | ETHYLHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENE | ANUBIS COSMETICS SL | ec83846f-11c0-8f59-e053-2995a90ab9d2 | 2023-09-01 | Warnings | ETJ7Z6XBU4 |
| Anubis Barcelona Spa Line | ORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACID | ANUBIS COSMETICS SL | eb01a962-ab38-18ec-e053-2995a90acdeb | 2023-09-01 | Warnings | 4ELV7Z65AP |
| Hydrate II | COFFEA TOSTA, AVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORMATUM, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEA | BioActive Nutritional, Inc. | 2d3657d9-d4f4-426c-b381-dbfde9b8e2cd | 2023-09-01 | Warnings | ETJ7Z6XBU4 |
| topcare allergy and congestion relief | LORATADINE, PSEUDOEPHEDRINE SULFATE | Topco Associates LLC | 32945cd9-60d4-4dc0-96e6-9ed28ffce3fb | 2023-08-29 | Warnings | 7AJO3BO7QN |
| Loratadine and Pseudoephedrine Sulfate | LORATADINE AND PSEUDOEPHEDRINE SULFATE | Meijer Distribution, Inc. | eb6e2196-2f4f-4fe9-9c80-b4ce89da8db4 | 2023-08-23 | Warnings | 7AJO3BO7QN |
| KIRKLAND SIGNATURE ALLERCLEAR D 24 HR Extended Release | LORATADINE AND PSEUDOEPHEDRINE SULFATE | Kirkland-COSTCO WHOLESALE COMPANY | b8e35d9f-5ad7-4cd5-b359-18f7dfe586c6 | 2023-08-23 | Warnings | 7AJO3BO7QN |
| BABY MUCUS PLUS COLD RELIEF | BRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDE | Hyland's Inc. | d934cc8a-1e43-4942-858a-05b5d068679a | 2023-08-22 | Warnings | ETJ7Z6XBU4 |
| B HP | APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), LACHESIS MUTUS, MERCURIUS SOLUBILIS, PULSATILLA (VULGARIS), PYROGENIUM, RHUS TOX, SILICEA | Energique, Inc. | 8b1414d5-57d8-46d5-b4be-3011429bdd0d | 2023-08-21 | Warnings | ETJ7Z6XBU4 |
| Pituistat | ARALIA QUINQUEFOLIA, GINKGO BILOBA, ARSENICUM IODATUM, AVENA SATIVA, BARYTA CARBONICA, PHOSPHORUS, SILICEA, THYROIDINUM (SUIS), ALUMINUM, ANTIMONY, BARIUM, BERYLLIUM, BISMUTH, BORON, BROMINE, CALCIUM, CARBON, CERIUM, CESIUM, CHLORIDE, CHROMIUM, COBALT, COPPER, DYSPROSIUM, ERBIUM, EUROPIUM, FLUORIDE, GADOLINIUM, GALLIUM, GERMANIUM, GOLD, HAFNIUM, HOLMIUM, INDIUM, IODINE, IRIDIUM, IRON, LANTHANUM, LITHIUM, LUTETIUM, MAGNESIUM, MANGANESE, MOLYBDENUM, NEODYMIUM, NICKEL, NIOBIUM, OSMIUM, PALLADIUM | Energique, Inc. | 27a5fccb-8707-4bb5-a848-d1921bba2f7f | 2023-08-21 | Warnings | ETJ7Z6XBU4 |
| Non-Drowsy Allergy Relief | LORATADINE TABLET | Lil' Drug Store Products, Inc. | 031fc3e5-b5eb-447c-e063-6294a90a13b5 | 2023-08-17 | Warnings | 7AJO3BO7QN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.