NDC 69339-152-01 - Diphenhydramine HCl Oral Solution

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
69339-152
Requested NDC
69339-152-01
Package NDCs from labels
69339-152-01, 69339-152-17, 69339-152-19
Manufacturer
Natco Pharma USA LLC
Effective date
2023-11-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Diphenhydramine HCl Oral Solution - Natco Pharma USA LLCNatco Pharma USA LLC2023-11-01HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69339-152-01Diphenhydramine HCl Oral Solution10 mL in 1 CUP, UNIT-DOSESOLUTION106
69339-152-17Diphenhydramine HCl Oral Solution4 in 1 CASESOLUTION46
69339-152-17Diphenhydramine HCl Oral Solution10 in 1 TRAYSOLUTION106
69339-152-19Diphenhydramine HCl Oral Solution10 in 1 CASESOLUTION106
69339-152-19Diphenhydramine HCl Oral Solution10 in 1 TRAYSOLUTION106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69339-152DIPHENHYDRAMINE HCL ORAL SOLUTION (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [NATCO PHARMA USA LLC]6Current NDC, Legacy NDC, 5 package rows20231102_54b64354-ac10-42ff-a53d-96cef933a91a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69339-152-01ML - Milliliter69339-152647442f3-f072-4ea8-b0e3-43cbbc52d60912021-01-08
69339-152-17ML - Milliliter69339-152b053be9b-804f-4cfe-b7b9-6cfde7ecb26f12021-01-08
69339-152-19ML - Milliliter69339-152da851f3d-9a4a-431d-9e74-005b6279e35412021-01-08

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 126 of 275 · 5,483 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Robitussin Day and Night Maximum Strength Cough DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATEHaleon US Holdings LLCb43d8fbd-1977-4465-aa64-79e7b7f54e092025-11-07WarningsExact identifier
application number: M012
Allergy plus Sinus HeadacheACETAMINOPHEN 325 MG, DIPHENHYDRAMINE HCL 12.5 MG, PHENYLEPHRINE HCL 5 MGShield Pharmaceuticals Corp093649a4-f968-49bd-83af-bb7e0f448ecf2025-11-07WarningsExact identifier
application number: M012
unii: TC2D6JAD40
TARGET Childrens Cold and CoughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRTARGET CORPORATIONbfc91c71-0506-4e94-8bfe-dc9e4bf959da2025-11-07WarningsExact identifier
application number: M012
SODIUM CHLORIDESODIUM CHLORIDEHenry Schein, Inc.2e81ffca-05c6-4fa0-8911-4b3cbfa713512025-11-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDERising Pharma Holdings, Inc.42870188-b1d7-4934-a6c0-310530497dac2025-11-07WarningsExact identifier
unii: 451W47IQ8X
CHILDRENS COLD AND COUGHBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEH E B08f4785a-c628-4e9b-9412-b2a817f9be602025-11-07WarningsExact identifier
application number: M012
Sodium ChlorideSODIUM CHLORIDEHenry Schein, Inc.d8b8d796-bfba-42af-a859-99d7768715582025-11-07Adverse reactionsExact identifier
unii: 451W47IQ8X
G-TUSICOFDEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINEKramer Novisd169585f-b4f4-4831-8c71-e1533ae7e7c42025-11-07WarningsExact identifier
application number: M012
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic Sodium ChlorideSODIUM CHLORIDEHenry Schein, Inc.31188cdf-7bc8-4d78-bfaf-c1dc9f851fd42025-11-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCLQUALITY CHOICE (Chain Drug Marketing Association)1d512053-7a54-4691-a657-77da4c627cb82025-11-07WarningsExact identifier
application number: M012
Allergy and HeadacheACETAMINOPHEN, DIPHENHYDRAMINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDdc249163-26dd-42ca-b423-2f16299f2d652025-11-07WarningsExact identifier
application number: M012
unii: TC2D6JAD40
Sinus CongestionPSEUDOEPHEDRINE HCLChain Drug Marketing Association, Inc.9744d04d-298d-4acd-9470-db9e7f2901e72025-11-07WarningsExact identifier
application number: M012
Daytime, Nighttime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDc3b7fab1-f7fe-41be-a1c4-7ba4ba23c1592025-11-07WarningsExact identifier
application number: M012
Severe Cold and Flu Relief Daytime/NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICE1c0c562a-68dc-4e9a-b8f3-ae70b9a4948e2025-11-07WarningsExact identifier
application number: M012
Vicks DayQuil HIGH BLOOD PRESSURE COLD and FLUACETAMINOPHEN, DEXTROMETHORPHAN HBRThe Procter & Gamble Manufacturing Companyff0bffee-9a36-8246-e053-6294a90a86c72025-11-06WarningsExact identifier
application number: M012
Xlear Nasal DecongestantNASAL SPRAYXlear Inc.1c1db71a-47d0-42ac-8cbe-95e76dca185f2025-11-06WarningsExact identifier
application number: M012
Extra Strength Itch ReliefDIPHENHYDRAMINE HCL AND ZINC ACETATEChain Drug Marketing Association Inc1a2997bc-7741-e658-e063-6394a90af6fd2025-11-06WarningsExact identifier
unii: TC2D6JAD40
Diphenhydramine HCl and Zinc AcetateEXTRA STRENGTH ITCH RELIEF CONTINUOUS SPRAYTopco Associates LLC8026c7dd-eb7b-ebea-e053-2991aa0a1b0f2025-11-06WarningsExact identifier
unii: TC2D6JAD40
Diphenhydramine HCl and Zinc AcetateEXTRA STRENGTH ITCH RELIEFWalgreen Company6057b4ff-6adc-4688-893c-62d237d7d1ae2025-11-06WarningsExact identifier
unii: TC2D6JAD40

Reported adverse events (FAERS/openFDA)#

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