FDA.reportPublic FDA data

NDC 62135-774-10 - PROMETHAZINE HYDROCHLORIDE

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
62135-774
Requested NDC
62135-774-10
Package NDCs from labels
62135-774-41, 62135-774-47, 62135-774-05, 62135-774-24, 62135-774-10, 62135-774-23
Manufacturer
Chartwell RX, LLC
Effective date
2026-01-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PROMETHAZINE HYDROCHLORIDE - Chartwell RX, LLCChartwell RX, LLC2026-01-30HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
62135-774-232025-09-30PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION, USP
62135-774-242025-09-30PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION, USP
62135-774-412025-09-30PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION, USP
62135-774-472025-09-30PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION, USP
62135-774-232025-07-29PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION, USP
62135-774-242025-07-29PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION, USP
62135-774-412025-07-29PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION, USP
62135-774-472025-07-29PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-774-05PROMETHAZINE HYDROCHLORIDE5 mL in 1 CUPSOLUTION54
62135-774-10PROMETHAZINE HYDROCHLORIDE10 mL in 1 CUPSOLUTION104
62135-774-23PROMETHAZINE HYDROCHLORIDE2 in 1 BOXSOLUTION24
62135-774-23PROMETHAZINE HYDROCHLORIDE10 in 1 TRAYSOLUTION104
62135-774-24PROMETHAZINE HYDROCHLORIDE10 in 1 TRAYSOLUTION104
62135-774-24PROMETHAZINE HYDROCHLORIDE2 in 1 BOXSOLUTION24
62135-774-41PROMETHAZINE HYDROCHLORIDE120 mL in 1 BOTTLESOLUTION1204
62135-774-47PROMETHAZINE HYDROCHLORIDE473 mL in 1 BOTTLESOLUTION4734

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-774PROMETHAZINE HYDROCHLORIDE SOLUTION [CHARTWELL RX, LLC]2Current NDC, 8 package rows20250215_2ca17cd4-460e-4d54-8c53-a58a2b80e5cb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-774-05ML - Milliliter62135-77450c92e2b-9e09-45ba-a355-e13a46e34cde12025-03-04
62135-774-10ML - Milliliter62135-77401f79f3d-79a8-4f33-bf9a-36051de1795f12025-03-04
62135-774-23ML - Milliliter62135-7748bb32fe0-a530-4cb1-afa4-46f41a5213e112025-03-04
62135-774-24ML - Milliliter62135-774ef63ecf3-8568-4690-83c8-d38e05ba8e3712025-03-04
62135-774-41ML - Milliliter62135-7747a928ca5-21f5-468b-9a56-b7cfce91b4ae12023-12-05
62135-774-47ML - Milliliter62135-77429586084-c3f6-49d2-9b13-b1ad57b6630a12023-12-05

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 1 of 179 · 3,562 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Advanced Alcohol Gel SanitizerALCOHOLBetco Corporation, Ltda23b997c-b010-5985-e053-2995a90aadf32026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Cotton CandyALCOHOLChurch & Dwight Co., Inc.5b107dd2-a76c-9c80-e063-6394a90aaedb2026-09-09WarningsExact identifier
unii: 3K9958V90M
Pink Touchland Power Mist Hydrating Hand Sanitizer Wild WatermelonALCOHOLChurch & Dwight Co., Inc.5b108f13-6474-fdbd-e063-6294a90a1a2b2026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Mango PassionALCOHOLChurch & Dwight Co., Inc.5b1099ae-f1e8-b79d-e063-6394a90add6f2026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Gentle Mist Hand Sanitizer Lily of The ValleyALCOHOLChurch & Dwight Co., Inc.5b10a3a7-1cca-2a34-e063-6294a90a3f6c2026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Glow Mist Hand Sanitizer RosewaterALCOHOLChurch & Dwight Co., Inc.5a850866-bc5d-e595-e063-6394a90a335f2026-09-09WarningsExact identifier
unii: 3K9958V90M
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEDIRECT RXbae9c9c1-107f-0fcb-e053-2a95a90a75b22026-09-09Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
hand sanitizer - cherry sundaeALCOHOLGanzhou Olivee Cosmetic Co., Ltd.270d2ce0-6310-4a84-be8a-72db6062bae72026-09-07WarningsExact identifier
unii: 3K9958V90M
hand sanitizer - vanilla frostingALCOHOLGanzhou Olivee Cosmetic Co., Ltd.f6cabda2-6e1c-4238-9a2e-df10e263517d2026-09-07WarningsExact identifier
unii: 3K9958V90M
hydrating mist hand sanitizer with silicone keychain holder - beaver nuggetsALCOHOLGanzhou Olivee Cosmetic Co., Ltd.ba3612b3-9696-417a-ba66-eb9dc5ea27c62026-09-07WarningsExact identifier
unii: 3K9958V90M
hydrating mist hand sanitizer with silicone keychain holder - signature scentALCOHOLGanzhou Olivee Cosmetic Co., Ltd.5b0ac694-66e0-437f-86cd-09f259344b892026-09-07WarningsExact identifier
unii: 3K9958V90M
Sweethearts - Crush On You - Peach SkinALCOHOLScent Theory Products LLC5ac32582-d888-edf4-e063-6394a90a40ab2026-09-05WarningsExact identifier
unii: 3K9958V90M
Sweethearts - Be Mine - Sugared BerriesALCOHOLScent Theory Products LLC5ac32ffb-926a-f249-e063-6394a90a8d872026-09-05WarningsExact identifier
unii: 3K9958V90M
Sweethearts - UR Sweet - Sweet Cherry Hand SanitizerALCOHOLScent Theory Products LLC5ac33b21-9192-8baa-e063-6294a90a6e752026-09-05WarningsExact identifier
unii: 3K9958V90M
Sweethearts - Ooo La La - Banana Cream Hand SanitizerALCOHOLScent Theory Products LLC5ac34dda-fbdf-0ca7-e063-6394a90ab7642026-09-05WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Salted Caramel Scented Hydrating Hand sanitizerALCOHOLChurch & Dwight Co., Inc.5aaa5f5b-7a8b-e887-e063-6294a90a9be52026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Peppermint Mocha Scented Hydrating Hand sanitizerALCOHOLChurch & Dwight Co., Inc.5aaa72fe-7667-fb21-e063-6294a90a5e112026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Spiced Pumpkin tini Scented Hydrating Hand sanitizerALCOHOLChurch & Dwight Co., Inc.5aaa809e-71b8-7498-e063-6394a90a9ff82026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Hello Kitty Power Mist Hand Sanitizer Berry BlissALCOHOLChurch & Dwight Co., Inc.5aaa8d3c-e386-1527-e063-6294a90a07ac2026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Cinnamon GingerbreadALCOHOLChurch & Dwight Co., Inc.5aaa9d84-3f84-223e-e063-6294a90a79fb2026-09-04WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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