FDA.reportPublic FDA data

NDC 68084-549-11 - Temazepam

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
68084-549
Requested NDC
68084-549-11
Package NDCs from labels
68084-549-11, 68084-549-21
Manufacturer
American Health Packaging
Effective date
2025-11-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Temazepam - American Health PackagingAmerican Health Packaging2025-11-13HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-549-11Temazepam1 in 1 BLISTER PACKCAPSULE110
68084-549-21Temazepam30 in 1 BOX, UNIT-DOSECAPSULE3010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-549TEMAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]9Current NDC, Legacy NDC, 2 package rows20240131_a3f06243-fa03-4cbd-951a-144ec43dcdfd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-549-11EA - Each68084-549726f3428-2014-47cd-94bd-bdd0c397fa2112013-02-13
68084-549-21EA - Each68084-549fca83a96-71b3-448d-91b4-b5c1fa7718bb12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TEMAZEPAMACTIVE INGREDIENTCHB1QD2QSSTEMAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]3
TEMAZEPAMACTIVE MOIETYCHB1QD2QSSTEMAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MTEMAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]3
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3TEMAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]3
ETHYL ACETATEINACTIVE INGREDIENT76845O8NMZTEMAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTEMAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]3
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYTEMAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TEMAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]3
GELATININACTIVE INGREDIENT2G86QN327LTEMAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GTEMAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TEMAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]3
SHELLACINACTIVE INGREDIENT46N107B71OTEMAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTEMAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]3

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 249 · 4,962 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
temazepamTEMAZEPAMBryant Ranch Prepackac08a51c-6c54-40da-9626-a4c82f337a3a2026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198241
unii: CHB1QD2QSS
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
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
temazepamTEMAZEPAMBryant Ranch Prepack5d83e474-0932-49ae-ad92-ca278cd5f1d52026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198242
unii: CHB1QD2QSS
temazepamTEMAZEPAMBryant Ranch Prepack1c08d30d-7c27-a09a-5240-7050771d5cc72026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198242
unii: CHB1QD2QSS
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
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Touchland Power Mist Salted Caramel Scented Hydrating Hand sanitizerALCOHOLChurch & Dwight Co., Inc.5aaa5f5b-7a8b-e887-e063-6294a90a9be52026-09-04WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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