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 |
|---|---|---|---|---|---|---|
| BM BM5 DROPS | APIS MELL, BAPTISIA, CONIUM MAC, ECHINACEA, EUPATORIUM PERF, SILICEA, THUJA OCC | BM Private Limited | 53e763ee-9a44-a914-e063-6394a90aeb3c | 2026-06-10 | Warnings | ETJ7Z6XBU4 |
| GUNA-BOWEL | ALOE - ALUMINUM OXIDE - BRYONIA ALBA ROOT - CHELIDONIUM MAJUS - CHOLECALCIFEROL - COLLINSONIA - FRANGULA ALNUS BARK - NIACIN - PANTOTHENIC ACID - POTASSIUM CARBONATE - RHUBARB - SILYBUM MARIANUM SEED - SKATOLE - SODIUM CARBONATE - STRYCHNOS NUX-VOMICA SEED - SUS SCROFA COLON - SUS SCROFA RECTUM - TARAXACUM OFFICINALE - THIAMINE - | Guna spa | 75465821-a889-4697-b470-e9588a523205 | 2026-06-10 | Warnings | LMI26O6933 |
| GUNA-AWARENESS | BETAINE - BUFO BUFO CUTANEOUS GLAND - CALCIUM CARBONATE - CHROMIC SULFATE - CICUTA VIROSA ROOT - COPPER - FOLIC ACID - GOLD - COBALAMIN - IRON - LACHESIS MUTA VENOM - MELATONIN - MOLYBDENUM - NEUROTROPHIN-3 - NEUROTROPHIN-4 - OXYTOCIN - SILICON DIOXIDE - SUS SCROFA FRONTAL LOBE - SUS SCROFA TEMPORAL LOBE - THYROTROPIN ALFA - UBIDECARENONE - VANADIUM - ZINC - BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN - | Guna spa | 10e46b39-7903-4390-b72d-865291245b4c | 2026-06-10 | Warnings | ETJ7Z6XBU4 |
| BM BIO28 ALCOHOL | CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA | BM Private Limited | 53d1c51a-77eb-bb3c-e063-6394a90aab3f | 2026-06-09 | Warnings | ETJ7Z6XBU4 |
| BM BIO18 | CALC FLUOR, CALC SULF, SILICEA. | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 53d3c1d6-d0ba-5ea7-e063-6394a90a0294 | 2026-06-09 | Warnings | ETJ7Z6XBU4 |
| BM Silicea | SILICEA | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 53bb3927-6053-eb3d-e063-6394a90a5ddf | 2026-06-08 | Warnings | ETJ7Z6XBU4 |
| Scrofularoforce | RUMEX CRISPUS, XANTHOXYLUM FRAXINEUM, LYMPH NODE (SUIS), SCROPHULARIA NODOSA, BARYTA CARBONICA, BARYTA MURIATICA, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, HELLEBORUS NIGER, IODIUM, KALI PHOSPHORICUM, LACHESIS MUTUS, NATRUM PHOSPHORICUM, SILICEA, JUNIPERUS VIRGINIANA | BioActive Nutritional, Inc. | 737cd410-0405-41b0-b7f2-29bb20037849 | 2026-06-08 | Warnings | ETJ7Z6XBU4 |
| VAX | BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), TABEBUIA IMPETIGINOSA, TRIFOLIUM PRATENSE, ARNICA MONTANA, CALENDULA OFFICINALIS, CHELIDONIUM MAJUS, LEPTANDRA VIRGINICA, LIGUSTICUM PORTERI, LOMATIUM DISSECTUM, MYRRHA, NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, TRIGONELLA FOENUM-GRAECUM, URTICA DIOICA, HYDRASTIS CANADENSIS, ASTRAGALUS MEMBRANACEUS, PROPOLIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, LYCOPODIUM CLAVATUM, RHUS TOX, SILICEA, | BioActive Nutritional, Inc. | faa4a678-321a-4982-a5d4-01b713e6862d | 2026-06-08 | Warnings | ETJ7Z6XBU4 |
| Borago Nicotiana | BORAGO NICOTIANA | Uriel Pharmacy Inc. | 306f9eee-877b-46ee-9a36-894fa321b3d3 | 2026-06-05 | Warnings | LMI26O6933 |
| Vermex | ARTEMISIA VULGARIS, CINA, TEUCRIUM MARUM, SPIGELIA ANTHELMIA, FILIX MAS, CALCAREA CARBONICA, GRAPHITES, MERCURIUS CORROSIVUS, SABADILLA, SILICEA, TANACETUM VULGARE, ASCARIS LUMBRICOIDES, TAENIA SOLIUM | BioActive Nutritional, Inc. | 6be5fbcf-bb22-4b20-b65a-d943c516adf9 | 2026-06-04 | Warnings | ETJ7Z6XBU4 |
| Loratadine | LORATADINE | Cardinal Health 107, LLC | 64489b01-a4a7-4c6d-ac84-1dfbd1388d84 | 2026-06-04 | Warnings | 7AJO3BO7QN |
| BM Silicea Icing Sugar | SILICEA ICING SUGAR | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 535ba100-627f-36b4-e063-6394a90a3373 | 2026-06-03 | Warnings | ETJ7Z6XBU4 |
| Loratadine and Pseudoephedrine | LORATADINE AND PSEUDOEPHEDRINE | Ohm Laboratories Inc. | 556b89ef-3b51-4faa-afb4-767a5c1b6422 | 2026-06-02 | Warnings | 7AJO3BO7QN |
| BM Tooth Remineralization | CALC PHOS, CALC FLUOR, SILICEA | BM Private Limited | 5331dc40-2ac8-5fce-e063-6394a90a5875 | 2026-06-01 | Warnings | ETJ7Z6XBU4 |
| Loratadine | LORATADINE | Preferred Pharmaceuticals Inc. | d778c4d2-184a-4dc8-9351-66d81d0618f2 | 2026-05-28 | Warnings | 7AJO3BO7QN |
| Good Sense childrens allergy relief | LORATADINE | Preferred Pharmaceuticals Inc. | 27bb0a40-35ee-4c19-bd6f-fb054c8a2586 | 2026-05-28 | Warnings | 7AJO3BO7QN |
| Loratadine | LORATADINE | Preferred Pharmaceuticals Inc | 0a0d700d-bdba-4c90-a947-5d61d40ce4df | 2026-05-28 | Warnings | 7AJO3BO7QN |
| Loratadine | LORATADINE | Preferred Pharmaceuticals Inc. | c6144a33-6b33-4aca-86e5-a3f688b8b317 | 2026-05-28 | Warnings | 7AJO3BO7QN |
| allergy relief | LORATADINE | Rite Aid Corporation | 5d58ed7a-e40b-417f-a216-5ec6721d361b | 2026-05-27 | Warnings | 7AJO3BO7QN |
| Alka-Seltzer Original | ANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATE | Select Consumer Group | 3ca80d74-1e8b-49d9-e063-6394a90a4312 | 2026-05-24 | Warnings | XF417D3PSL |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.