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 3 of 246 · 4,917 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Touchland Power Mist Hand Sanitizer Citrus GroveALCOHOLChurch & Dwight Co., Inc.5a84344b-4ddb-32e5-e063-6394a90a628b2026-09-02WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hand Sanitizer Frosted MintALCOHOLChurch & Dwight Co., Inc.5a8445e6-42cc-3e55-e063-6394a90ac0e12026-09-02WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hand Sanitizer Lemon Lime SpritzALCOHOLChurch & Dwight Co., Inc.5a84870b-e539-9dd8-e063-6294a90aaf0b2026-09-02WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hand Sanitizer Pure LavenderALCOHOLChurch & Dwight Co., Inc.5a848ff6-fbdd-a76c-e063-6294a90a324b2026-09-02WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hand Sanitizer RainwaterALCOHOLChurch & Dwight Co., Inc.5a84969c-aa38-aeb7-e063-6294a90a69422026-09-02WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hand Sanitizer UnscentedALCOHOLChurch & Dwight Co., Inc.5a84d2e3-d839-f7c6-e063-6294a90aa32f2026-09-02WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hand Sanitizer Beach CocoALCOHOLChurch & Dwight Co., Inc.5a84db79-1bab-fff8-e063-6294a90aab372026-09-02WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hand Sanitizer Velvet PeachALCOHOLChurch & Dwight Co., Inc.5a84ed55-f41d-d05f-e063-6394a90ad0122026-09-02WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hand Sanitizer AppleliciousALCOHOLChurch & Dwight Co., Inc.5a84fbeb-dd64-26ce-e063-6294a90aa8562026-09-02WarningsExact identifier
unii: 3K9958V90M
Smart Care SQUISHMALLOWS Pretty Petal Scented HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.3884e292-1f03-4e08-90d9-82b601c0c5c22026-09-02WarningsExact identifier
unii: 3K9958V90M
Smart Care VANILLA FIG HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.c5490afe-b2b4-4c6c-910f-af828362d6a42026-09-02WarningsExact identifier
unii: 3K9958V90M
TemazepamTEMAZEPAMMajor Pharmaceuticals2c4f564d-d349-4f9b-b3f4-f3f0d9706a4d2026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198243
unii: CHB1QD2QSS
Smart Care MISTLETOE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.fca4510f-f130-464c-ade4-fe05bdae3e7b2026-09-01WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer,2pk -Gingerbread and Cherry CobblerALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a52731b-5e8c-5ae6-e063-6394a90a8b042026-08-31WarningsExact identifier
unii: 3K9958V90M
hydrating mist hand sanitizer with silicone keychain holder - beaver nuggetsALCOHOLGanzhou Olivee Cosmetic Co., Ltd.f875e065-7b3e-45dc-8a33-b893ab8306952026-08-31WarningsExact identifier
unii: 3K9958V90M
hydrating mist hand sanitizer with silicone keychain holder - signature scentALCOHOLGanzhou Olivee Cosmetic Co., Ltd.30e11bf0-1a21-45b1-adf9-cf3845419a982026-08-31WarningsExact identifier
unii: 3K9958V90M
Swisher Instant Hand Sanitizer GelALCOHOLEcolab Inc.1f84e842-ece4-4eb7-9ccf-d86cec78dbf22026-08-31WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer(Oval Shape)with Beaded Wristlet - Cherry BlossomALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a4fb4b6-ba9e-5b82-e063-6294a90a47342026-08-30WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer with Woven Lanyard and Chainendants- WatermelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a503581-061b-0050-e063-6294a90af48a2026-08-30WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer,2pk-Christmas Rose and Candy CaneALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a50402b-e4d7-3c0b-e063-6394a90a5e522026-08-30WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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