FDA.reportPublic FDA data

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 103 of 276 · 5,503 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
sugar free honey lemon cough dropsMENTHOLMeijer5bd7c24d-6a61-5d2d-e053-2a91aa0a08ed2025-12-18WarningsExact identifier
application number: M012
SF Honey Lemon Cough DropsMENTHOLMeijer Distribution70e3de9a-1804-ef15-e053-2a95a90a33402025-12-18WarningsExact identifier
application number: M012
Acetaminophen Diphenhydramine HClACETAMINOPHEN DIPHENHYDRAMINE HCLBETTER LIVING BRANDS LLC.ac0f8d5c-d200-1156-e053-2a95a90aece62025-12-18WarningsExact identifier
unii: TC2D6JAD40
Naproxen Sodium Diphenhydramine HydrochlorideNAPROXEN SODIUM DIPHENHYDRAMINE HYDROCHLORIDESAFEWAYed0f3275-f156-13a3-e053-2a95a90a2ce82025-12-18WarningsExact identifier
unii: TC2D6JAD40
A Health Itch Relief GelITCH RELIEF GELBionpharma, Inc.ecf5decb-c98b-7739-e053-2995a90a55412025-12-18WarningsExact identifier
unii: TC2D6JAD40
QUALITY CHOICE Cough Drops Vanilla HoneyMENTHOLChain Drug Marketing Association, Inc.3d6a4bcc-1044-40f5-928a-378ececcb6872025-12-18WarningsExact identifier
application number: M012
Meijer Strawberry Cough DropsMENTHOLMeijer164de637-e644-711c-e063-6294a90a1c5f2025-12-18WarningsExact identifier
application number: M012
Meijer Severe Menthol Throat DropsMENTHOLMeijer16603ca4-1ce5-2e7e-e063-6394a90ad6f12025-12-18WarningsExact identifier
application number: M012
LemonGLYCERINTwinMed LLCfc88eec0-c66c-5d6d-e053-6294a90a13d22025-12-18WarningsExact identifier
unii: PDC6A3C0OX
Allergy Relief ChildrensDIPHENHYDRAMINE HCLA-S Medication Solutions60587987-c303-4617-ba96-c518ab2a06502025-12-18WarningsExact identifier
application number: M012
rxcui: 1049906
unii: TC2D6JAD40
Body BalanceARALIA QUIN, ARNICA, AVENA, CARDUUS MAR, ELAEIS, GLANDULA SUPRARENALIS SUIS, NAT MUR, PHOSPHORICUM AC, THUJA OCCEight and Company L.L.C876cc0cf-c7a7-4656-adf9-1eff9bb626872025-12-18WarningsExact identifier
unii: 451W47IQ8X
ADRENOPLEXCHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), GLANDULA SUPRARENALIS BOVINE, SPLEEN (SUIS), CARDUUS MARIANUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUMBioActive Nutritional, Inc.3c53c23e-7654-4e46-acf1-edb0d605ff3b2025-12-18WarningsExact identifier
unii: 451W47IQ8X
VermasodeARTEMISIA VULGARIS, CHELIDONIUM MAJUS, GRANATUM, SPIGELIA ANTHELMIA, RATANHIA, ARSENICUM ALBUM, FERRUM METALLICUM, CALCAREA CARBONICA, CINA, GAERTNER BACILLUS, GRAPHITES, MERCURIUS DULCIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, VERMIN NOSODENatural Creations, Inc180b5641-5692-42d4-8472-fdadccebd7462025-12-18WarningsExact identifier
unii: 451W47IQ8X
NiafluDEXTROMETHORPHAN HBR, GUAIFENESINPharmadel LLC399898f0-e40a-4f5d-e063-6294a90a667d2025-12-17WarningsExact identifier
application number: M012
HZ-ChordBAPTISIA TINCTORIA, CEANOTHUS AMERICANUS, CITRICUM ACIDUM, ECHINACEA (ANGUSTIFOLIA), GELSEMIUM SEMPERVIRENS, HYDROCOTYLE ASIATICA, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, MEZEREUM, MORBILLINUM, NUX VOMICA, PALOONDO, PHYTOLACCA DECANDRA, SEPIA, THUJA OCCIDENTALIS, THYROIDINUM (BOVINE)Energetix Corporation9685aec5-a65d-40fe-b5d7-2f13a69733bc2025-12-17WarningsExact identifier
unii: XF417D3PSL
ReHydrationADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KALI PHOS, NAT MUR, SARSAPARILLA, SILICEA, TARAXACUM, THYROIDINUMEnergetix Corporation9b532a31-530a-44f9-843f-f395a3e460b82025-12-17WarningsExact identifier
unii: 451W47IQ8X
Cherry cough dropMENTHOLThe Kroget Co.4313a6ce-454d-4c4b-e054-00144ff88e882025-12-17WarningsExact identifier
application number: M012
Menthol cough dropMENTHOLThe Kroger Co.42b257e9-f45e-32c9-e054-00144ff8d46c2025-12-17WarningsExact identifier
application number: M012
Honey Lemon cough dropMENTHOLThe Kroger Co.4318f25a-05d9-2208-e054-00144ff88e882025-12-17WarningsExact identifier
application number: M012
Honey Lemon cough dropMENTHOLThe Kroger Co.4317f952-a228-0281-e054-00144ff88e882025-12-17WarningsExact identifier
application number: M012

Reported adverse events (FAERS/openFDA)#

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