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 |
|---|---|---|---|---|---|---|
| LORATADINE | LORATADINE | Bionpharma Inc. | 59bebce3-2b82-4521-a796-2d4c83bcf669 | 2019-01-08 | Warnings | 7AJO3BO7QN |
| Skin Klear Acne Relief | TRIBASIC CALCIUM PHOSPHATE, FUMARIA OFFICINALIS FLOWERING TOP, ARCTIUM LAPPA ROOT, SODIUM CHLORIDE, SAPONARIA OFFICINALIS ROOT, SILICON DIOXIDE, SOLIDAGO VIRGAUREA FLOWERING TOP, SULFUR, VIOLA TRICOLOR | Homeocare Laboratories | 65afbc20-611b-4bc4-a151-c633bec66a82 | 2018-12-31 | Warnings | ETJ7Z6XBU4 |
| Sinus Relief | ASAFETIDA, ECHINACEA ANGUSTIFOLIA, CALCIUM SULFIDE, POTASSIUM DICHROMATE, LUFFA OPERCULATA WHOLE, SILICON DIOXIDE, SINUSITISINUM | Homeocare Laboratories | 84483171-df92-47de-9203-ed02d64fb5fb | 2018-12-31 | Warnings | ETJ7Z6XBU4 |
| Hair-X Hair Loss Relief | CADMIUM SULFATE, GRAPHITE, PHOSPHORIC ACID, SILICON DIOXIDE, SELENIUM, THALLIUM, USTILAGO MAYDIS | Homeocare Laboratories | 00b62179-e03b-4972-902d-3a0c969b59bc | 2018-12-31 | Warnings | ETJ7Z6XBU4 |
| GUNA-SINUS NOSE | ALTHAEA OFFICINALIS LEAF - ASCORBIC ACID - BLACK CURRANT - CALCIUM SULFIDE - COPPER - ECHINACEA ANGUSTIFOLIA - GOLDENSEAL - LACHESIS MUTA VENOM - LOBARIA PULMONARIA - MANGANESE - MERCURIC SULFIDE - ONION - PLANTAGO MAJOR - POTASSIUM CARBONATE - PULSATILLA VULGARIS - SILICON DIOXIDE - SILVER NITRATE - SINUSITISINUM - SUS SCROFA NASAL MUCOSA - SUS SCROFA THYMUS - SUS SCROFA URINARY BLADDER - | Guna spa | 36fef678-17c6-4d2a-a0f0-ddb298611f25 | 2018-12-22 | Warnings | ETJ7Z6XBU4 |
| Gastrozen | COFFEA TOSTA, GLYCYRRHIZA, PHYTOLACCA, TARAXACUM, HYDRASTIS, ARSENICUM ALB, GELSEMIUM, MERC SOLUB, NITRICUM AC, NUX VOM, PETROLEUM, PHOSPHORICUM AC, PHOSPHORUS, BROMIUM, CADMIUM SULPHURICUM, CINCHONA, CONIUM, HYDROGEN, IODIUM, LACHESIS, PULSATILLA, SILICEA, SULPHURICUM AC | Natural Creations, Inc | 98dd756f-6774-47c3-bdfb-deff82fb801d | 2018-12-21 | Warnings | ETJ7Z6XBU4 |
| H.M.D. | ALLIUM SAT, AVENA, BERBER VULG, LAPPA, PHYTOLACCA, SOLIDAGO, ALUMINA, ARG NIT, BARYTA CARB, BERYLLIUM, CADMIUM MET, CURPRUM MET, FLUORICUM ACIDUM, INDIUM, IODIUM, LITHIUM CARB, MERC SOLUB, NICCOLUM CARB, NITROGENUM OXYGENATUM, PLUMB MET, SELENIUM, STRONTIUM CARB, TITANIUM, ARSENICUM ALB, NAT MUR, NUX VOM | Zorex International | 8c53091a-904d-4756-93e4-17143c5b48e9 | 2018-12-21 | Warnings | LMI26O6933 |
| Runny Nose CP | ALLIUM CEPA, CALC CARB, FERRUM PHOS, HEPAR SULPH CALC, LYCOPODIUM, MERC SOLUB, PULSATILLA, SILICEA, SULPHUR | Natural Creations, Inc | 868ec0ad-9344-4f94-b2c1-2abb48479b15 | 2018-12-21 | Warnings | ETJ7Z6XBU4 |
| Mold Antigen | ALTERNARIA ALTERNATA, ASPERGILLUS FUMIGATUS, ASPERGILLUS NIGER, BOLETUS SAT, BOTRYTIS CINEREA, CLADOSPORIUM METANIGRUM, FUSARIUM OXYSPORUM, HELMINTHOSPORIUM, MUCOR MUECEDO, PULLULARIA PULLULANS, RHIZOPUS NIGRICANS, USTILAGO MAYDIS, ARSENICUM ALB, CANDIDA ALB, CARBO AN, LACHESIS, LYCOPODIUM, MERC SOLUB, NITRICUM AC, PHOSPHORUS, PULSATILLA, SEPIA, SILICEA, THUJA OCC | Zorex International | ff92e909-b5a7-417f-98a4-551f1576fd1e | 2018-12-21 | Warnings | ETJ7Z6XBU4 |
| Nausea CP | AETHUSA CYNAPIUM, ANTIMON TART, ARSENICUM ALB, CALC CARB, CHAMOMILLA, CINCHONA, COCCUS, CUPRUM MET, FERRUM MET, IPECAC, KREOSOTUM, LYCOPODIUM, PETROLEUM, PULSATILLA, SILICEA, SULPHUR | Natural Creations, Inc | 2746cde1-577b-41d6-9f22-93d8f1a2c235 | 2018-12-21 | Warnings | ETJ7Z6XBU4 |
| Hydrate II | BERBER AQUI, BETA VULG, BOLDO, CARDUUS MAR, CHELIDONIUM MAJ, HORDEUM VULGARE, IRIS VERS, ROSMARINUS, TARAXACUM, AVENA, ELEUTHEROCOCCUS SENTICOSUS, XANTHOXYLUM, EQUISETUM HYEM, HYPERICUM, ULMUS FULV, GETTYSBURG AQUA, GLYCYRRHIZA, WILDBAD AQUA, CARLSBAD AQUA, ATP, HYDROGEN, NAT MUR, OXYGEN, SILICEA, WIESBADEN AQUA | Zorex International | e5f53495-3b75-4d7c-89af-23058fb6fd05 | 2018-12-21 | Warnings | ETJ7Z6XBU4 |
| Dust Mix Antigen | ANTIMON TART, ARSENICUM ALB, BLATTA OR, BROMIUM, CALC CARB, CIMEX, DROSERA, HEPAR SULPH CALC, ICTODES FOETIDA, LYCOPODIUM, PHOS, PULSATILLA, SILICEA TERRA, TABACUM FUMUS | Natural Creations, Inc | 8dab4b4a-6fa8-4258-adc1-f8c634e2030b | 2018-12-21 | Warnings | ETJ7Z6XBU4 |
| Allergy Relief | LORATADINE | Allegiant Health | 0991388a-2eb8-4913-9efc-adf411eddf3a | 2018-11-08 | Warnings | 7AJO3BO7QN |
| Loratadine and Pseudoephedrine Sulfate | LORATADINE AND PSEUDOEPHEDRINE SULFATE | Publix Super Markets Inc | 63b73a3e-4f3a-40f1-98c0-13a2bca4f4e0 | 2018-10-22 | Warnings | 7AJO3BO7QN |
| Loratadine Allergy Relief | LORATADINE | DISCOUNT DRUG MART | 55d3ee36-116b-4ec6-b409-79d67a2b54ae | 2018-09-14 | Warnings | 7AJO3BO7QN |
| Loratadine Allergy Relief | LORATADINE | WinCo Foods, LLC | 506a60e8-7fec-4bb0-babc-204058ae120f | 2018-08-29 | Warnings | 7AJO3BO7QN |
| Loratadine | LORATADINE | Valu Merchandisers Company | 0cd920b4-b15a-4ca9-87e2-4dd523c6d1f8 | 2018-08-28 | Warnings | 7AJO3BO7QN |
| Loratadine | LORATADINE | Chain Drug Marketing Association Inc. | b4edf5b1-398d-405a-8a42-76044b31ebb7 | 2018-08-27 | Warnings | 7AJO3BO7QN |
| CHILDRENS LORATADINE | LORATADINE | CVS PHARMACY, INC | 62e94727-cbb3-4c57-b241-161ab634c680 | 2018-08-03 | Warnings | 665078 7AJO3BO7QN |
| Additox | TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM | BioActive Nutritional, Inc. | 319ee2fe-58e3-495e-bf0d-df201f6fbb1c | 2018-07-18 | Warnings | Z0H242BBR1 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.