FDA.reportPublic FDA data

NDC 43378-102 - Zodryl AC 35

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
43378-102
Package NDCs from labels
43378-102-04
Manufacturer
CodaDose, Inc. | Gorbec Pharmaceutical Services Inc.
Effective date
2009-08-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ZODRYL AC 35 – chlorpheniramine maleate and codeine phosphate suspensionCodaDose, Inc. | Gorbec Pharmaceutical Services Inc.2009-08-24HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43378-102-042019-10-21C16284748780-1956f9ecf-dec6-621f-e053-dbdaa90a74adZODRYL AC 35 – chlorpheniramine maleate and codeine phosphate suspension

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43378-102-04Zodryl AC 35118 mL in 1 BOTTLE, PLASTICSUSPENSION1184

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43378-102ZODRYL AC 35 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]41 package rows20180616_07af42d8-4b0c-4cd1-b299-42dc12980b94.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43378-102-04ML - Milliliter43378-102ee3bcf16-dd09-4a29-8610-0a8e770c105212013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZZODRYL AC 40 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]1
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6ZODRYL AC 40 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]1
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UZODRYL AC 40 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]1
CODEINEACTIVE MOIETYQ830PW7520ZODRYL AC 40 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLZODRYL AC 40 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAZODRYL AC 40 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXZODRYL AC 40 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCZODRYL AC 40 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TZODRYL AC 40 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRZODRYL AC 40 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ZODRYL AC 40 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]1
TANNIC ACIDINACTIVE INGREDIENT28F9E0DJY6ZODRYL AC 40 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RZODRYL AC 40 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEZODRYL AC 40 (CHLORPHENIRAMINE MALEATE AND CODEINE PHOSPHATE) SUSPENSION [CODADOSE, INC.]1

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 28 of 46 · 920 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anticoagulant Citrate Dextrose A ACD-AANTICOAGULANT CITRATE DEXTROSE A ACD-AArteriocyte Medical Systems, Inc.b850deac-161f-4bb0-ac7f-bceac2a230c02025-01-23Exact identifier
unii: 1Q73Q2JULR
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEDirect_Rxe78e50c0-36da-528e-e053-2995a90a3d802025-01-22Warnings, Adverse reactionsExact identifier
unii: GSL05Y1MN6
OASIS Tears Lubricant EyeGLYCERINOASIS Medical, Inc.00071697-4ac6-4962-8eee-388b8b52bd402025-01-22WarningsExact identifier
unii: PDC6A3C0OX
ACD ADEXTROSE MONOHYDRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATETerumo BCT Ltd570770de-9b48-4fc1-a1ee-06002ca9504f2025-01-22Exact identifier
unii: 1Q73Q2JULR
OASIS Tears Plus Preservative-Free Lubricant EyeGLYCERINOASIS Medical, Inc.ea931c0f-c61e-4771-84f1-0274b1c3e28e2025-01-22WarningsExact identifier
unii: PDC6A3C0OX
Anticoagulant Citrate Dextrose (ACD-A)DEXTROSE MONOHYDRATE, SODIUM CITRATE, UNSPECIFIED FORM, AND CITRIC ACID MONOHYDRATETerumo BCT, Ltd0130d7c8-d067-4528-beb7-166559c33be92025-01-21Warnings, Adverse reactionsExact identifier
unii: 1Q73Q2JULR
PharbechlorCHLORPHENIRAMINE MALEATE 4MGUlai Health LLC6a1a5cef-e946-4ba8-9402-557c6adf45f92025-01-20WarningsExact identifier
unii: V1Q0O9OJ9Z
Medics Choice Soothing Eye WashPURIFIED WATERKC Pharmaceuticals, Inc.10e49808-161e-f4ec-e063-6294a90a17752025-01-19WarningsExact identifier
unii: 059QF0KO0R
Alka-Seltzer Plus Severe Cold PowerFast Fizz Orange ZestASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.a23a6db6-4585-2882-e053-2a95a90ab01a2025-01-17WarningsExact identifier
unii: V1Q0O9OJ9Z
Alka-Seltzer Plus Severe Cold Night PowerFast FizzASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.fc754dff-cecd-fc6b-e053-6394a90ab3712025-01-17WarningsExact identifier
unii: V1Q0O9OJ9Z
Glycerin LaxativeGLYCERIN BASED GENTLE AND EFFECTIVE LAXATIVE ADULT CONSTIPATION RELIEFNeilMed Pharmaceuticals Inc.03b4be69-6488-76be-e063-6394a90a7edf2025-01-17WarningsExact identifier
unii: PDC6A3C0OX
Beautyturess Collagen Moisturizing Firming 14-Piece SetBEAUTYTURESS COLLAGEN MOISTURIZING FIRMING 14-PIECE SETGuangdong Bisutang Biotechnology Co., Ltd.2bc94a8a-effb-8319-e063-6394a90a535d2025-01-15WarningsExact identifier
unii: PDC6A3C0OX
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATENuCare Pharmaceuticals, Inc.1e932a34-a7d3-e4ec-e063-6294a90a25b12025-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GSL05Y1MN6
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAvPAKfe070e2e-3e72-fb84-e053-6294a90afd882025-01-09Adverse reactionsExact identifier
unii: 1Q73Q2JULR
unii: XF417D3PSL
STERILE WATERSTERILE WATERHF Acquisition Co. LLC, DBA HealthFirst74ed2a6f-824c-a1ff-e053-2a91aa0a57c02025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst77bd3c0f-f4ab-7cfa-e053-2a91aa0a1b832025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst7610bf80-61b7-982f-e053-2a91aa0ac1bb2025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
T-27WATERDNA Labs, Inc.f0e9afd7-64a4-4b85-9c5f-4bf07ba4b4812025-01-09WarningsExact identifier
unii: 059QF0KO0R
Hemorrhoidal Cream with AloeGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMChain Drug Marketing Association2b33c710-ac17-20f9-e063-6294a90ad29c2025-01-08WarningsExact identifier
unii: PDC6A3C0OX
ANTIBACTERIAL DREAMY FLORALSGLYCERINQuimicas Handal de Centroamerica SA de CV09f73bec-516d-90f0-e063-6394a90aecab2025-01-08WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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