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 |
|---|---|---|---|---|---|---|
| Bio Co-Enzyme Phase | BETA VULGARIS, ASCORBICUM ACIDUM, CYSTEINUM, NATRUM OXALACETICUM, NICOTINAMIDUM, PULSATILLA (PRATENSIS), PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, ALPHA-KETOGLUTARICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CERIUM OXALICUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MAGNESIUM OROTICUM DIHYDRICUM, MALICUM ACIDUM, NADIDUM, NATRUM PYRUVICUM, PANTOTHENIC ACID, SUCCINICUM ACIDUM, ADRENALINUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, HEPAR SULPHURIS CALCAREUM, SULPHUR, ACONITICUM ACIDUM, CIS-, | Deseret Biologicals, Inc. | e8f6e2ec-ae2e-4bee-b9d3-5f3a2e3daf65 | 2022-05-09 | Warnings | XF417D3PSL |
| Loratadine and Pseudoephedrine | LORATADINE AND PSEUDOEPHEDRINE SULFATE | Rite Aid | bb0f7653-378f-40b1-8ead-77999fcbd87b | 2022-05-09 | Warnings | 7AJO3BO7QN |
| ACD Blood-Pack Units (PL 146 PLASTIC) | ANTICOAGULANT CITRATE DEXTROSE (ACD) | Fenwal, Inc. | ba894daa-688e-4a9e-bd74-e71797f951bb | 2022-04-27 | XF417D3PSL | |
| Allergy Relief | LORATADINE | AAA PHARMACEUTICAL, INC. | 9c8535e3-6a60-4640-b37e-a2260936d9af | 2022-04-21 | Warnings | 7AJO3BO7QN |
| signature care allergy relief | LORATADINE | Safeway | 0a4b8eef-762e-42cc-84ee-0018a9a3be58 | 2022-04-04 | Warnings | 7AJO3BO7QN |
| Loratadine antihistamine | LORATADINE | Proficient Rx LP | e9b87f79-ebed-4677-8e50-00cb4282ee56 | 2022-04-01 | Warnings | 7AJO3BO7QN |
| Leader Allergy Relief D-24 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | Cardinal Health | f1bcd2aa-e8cd-4364-87b4-c544537cdb50 | 2022-03-22 | Warnings | 7AJO3BO7QN |
| ALPHA SH | SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS | Schwabe Mexico, S.A. de C.V. | 3e2e5f52-db54-4635-83a8-a67a683c093c | 2022-03-22 | Warnings | ETJ7Z6XBU4 |
| ALPHA SH | SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS | Schwabe North America, Inc. | 94de9ce3-6ee9-4322-bda2-0b4391f09d87 | 2022-03-22 | Warnings | ETJ7Z6XBU4 |
| Ear Care | ECHINACEA, HYDRASTIS CANADENSIS, APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAPSICUM ANNUUM, CAUSTICUM, CINCHONA OFFICINALIS, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI SULPHURICUM, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, MEZEREUM, PHOSPHORUS, PLANTAGO MAJOR, PULSATILLA, SILICEA, VERBASCUM THAPSUS, TELLURIUM METALLICUM, INFLUENZINUM | Newton Laboratories, Inc. | da807eb3-34a3-61b9-e053-2995a90a0e21 | 2022-03-18 | Warnings | ETJ7Z6XBU4 |
| Ear Care | INFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTIS | Newton Laboratories, Inc. | da80a5ea-f603-719e-e053-2995a90a9710 | 2022-03-18 | Warnings | ETJ7Z6XBU4 |
| Ear Care | INFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTIS | Newton Laboratories, Inc. | da81b21a-090a-dabf-e053-2995a90aa05e | 2022-03-18 | Warnings | ETJ7Z6XBU4 |
| Ear Care | INFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTIS | Newton Laboratories, Inc. | da821d05-b2f0-3582-e053-2a95a90afe59 | 2022-03-18 | Warnings | ETJ7Z6XBU4 |
| Ear Care | ECHINACEA, HYDRASTIS CANADENSIS, APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAPSICUM ANNUUM, CAUSTICUM, CINCHONA OFFICINALIS, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI SULPHURICUM, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, MEZEREUM, PHOSPHORUS, PLANTAGO MAJOR, PULSATILLA, SILICEA, VERBASCUM THAPSUS, TELLURIUM METALLICUM, INFLUENZINUM | Newton Laboratories, Inc. | da717cf0-54af-c4e2-e053-2995a90ac97c | 2022-03-17 | Warnings | ETJ7Z6XBU4 |
| Loratadine | LORATADINE | Rising Pharmaceuticals, Inc | d28128a3-af54-440e-9bd4-0fccf393d18a | 2022-03-10 | Warnings | 7AJO3BO7QN |
| topcare childrens allergy | LORATADINE | Topco Associates LLC | 6e175fae-05dd-45c2-b9ab-7d49369a3c05 | 2022-02-28 | Warnings | 7AJO3BO7QN |
| topcare allergy and congestion relief | LORATADINE, PSEUDOEPHEDRINE SULFATE | Topco Associates LLC | dd93d172-2a3a-4e4c-a237-7668acbd537d | 2022-02-16 | Warnings | 7AJO3BO7QN |
| ACNE HP | CARBO ANIMALIS, ACTIVATED CHARCOAL, POTASSIUM DICHROMATE, SODIUM CHLORIDE, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, SULFUR, ZINC | Natural Creations, Inc. | b2368ab6-e233-4473-99fa-86e1fbc2a879 | 2022-02-14 | Warnings | ETJ7Z6XBU4 |
| ACD-A | ANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA A | Fenwal, Inc. | 22805f0d-ba58-41ea-b245-19980abcda22 | 2022-02-11 | XF417D3PSL | |
| EAR RX | ACONITUM NAP, BARYTA CARB, BELLADONNA, CALC CARB, CAPSICUM, CARBO VEG, CAUSTICUM, CHAMOMILLA, FERRUM PHOS, HEPAR SULPH CALC, KALI MUR, LACHESIS, LYCOPODIUM, MERCURIUS SOL, NATRUM MUR, PLANTAGO, PULSATILLA, SILICEA, SULPHUR, VERBASCUM | Miami Beach Pediatrics pa | a8753f88-4b8a-472f-a4bd-f2e9cec83610 | 2021-12-29 | Warnings | ETJ7Z6XBU4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.