fluocinolone acetonide 0.1 MG/ML Topical Solution
- RxCUI
- 1191310
- RxNorm name
- fluocinolone acetonide 0.1 MG/ML Topical Solution
- Display name
- Fluocinolone (Topical)
- Full name
- fluocinolone acetonide 0.1 MG/ML Topical Solution
- Term type
- SCD
- Status
- Active
- Strength
- 0.01%
- Dose form
- Sol
- Route
- Topical
- Updated
- 2026-07-18 07:00:12
RxNorm Status History#
- Status
- Active
- Source
- RXNORM
- Current
- YES
- Release start
- 112011
- Active start
- 112011
- Multiple ingredient
- NO
- Branded
- NO
Ingredients And Strength#
| Ingredient | Strength | Base | Basis of strength |
|---|---|---|---|
| fluocinolone acetonide | 0.1 MG / 1 ML | fluocinolone | fluocinolone acetonide |
Dose Form Concepts#
| Dose form | RxCUI |
|---|---|
| Topical Solution | 316986 |
Derived Ingredient Concepts#
| Ingredient | RxCUI |
|---|---|
| fluocinolone | 25126 |
Source Vocabulary Codes#
| Code type | Value | Category |
|---|---|---|
| PRESCRIBABLE | Y | ATTRIBUTES |
| RXNAV_STR | fluocinolone acetonide 0.1 MG/ML Topical Solution | NAMES |
| RxNorm Name | fluocinolone acetonide 0.1 MG/ML Topical Solution | NAMES |
| RxNorm Synonym | fluocinolone acetonide 0.01 % Topical Solution | NAMES |
| TTY | SCD | ATTRIBUTES |
| SPL_SET_ID | 02352ed1-3568-441f-add8-45201351a11c | CODES |
| SPL_SET_ID | 3fa4d5db-b17f-44dc-aa6a-50934d42c68d | CODES |
| SPL_SET_ID | 3fb00d90-6a5b-4e95-ab6b-f5b102ff0f36 | CODES |
| SPL_SET_ID | 460f5a55-6437-4651-bc08-8063ca579c8d | CODES |
| SPL_SET_ID | 5649e15a-6a7c-4752-ac28-01e453afb37e | CODES |
| SPL_SET_ID | 98dfd7a4-2208-4637-acf5-080a5813a433 | CODES |
| SPL_SET_ID | ce89966d-d7ea-4986-936e-6d46aee497cd | CODES |
| RxCUI | 1191310 | CODES |
| MMSL_CODE | BD3136 | CODES |
| MMSL_CODE | CD3136 | CODES |
| MMSL_CODE | CD7067 | CODES |
FDA NDC Products And Packages#
| Package NDC | Product NDC | Name | Labeler | Application |
|---|---|---|---|---|
| 0168-0059-60 | 0168-0059 | Fluocinolone Acetonide fluocinolone acetonide | Fougera Pharmaceuticals, LLC | ANDA088167 |
| 0591-2990-60 | 0591-2990 | Fluocinolone Acetonide Topical Fluocinolone Acetonide Topical | Actavis Pharma, Inc. | ANDA208386 |
| 21922-003-01 | 21922-003 | Fluocinolone Acetonide Topical Solution USP, 0.01% Fluocinolone Acetonide Topical Solution USP, 0.01% | Encube Ethicals, Inc. | ANDA209913 |
| 43386-069-60 | 43386-069 | Fluocinolone Acetonide Fluocinolone Acetonide | Lupin Pharmaceuticals,Inc. | ANDA206422 |
| 51672-1365-2 | 51672-1365 | Fluocinolone Acetonide fluocinolone acetonide | Sun Pharmaceutical Industries, Inc. | ANDA089124 |
| 51672-1365-4 | 51672-1365 | Fluocinolone Acetonide fluocinolone acetonide | Sun Pharmaceutical Industries, Inc. | ANDA089124 |
| 63629-9584-1 | 63629-9584 | Fluocinolone Acetonide Topical Solution USP, 0.01% Fluocinolone Acetonide Topical Solution USP, 0.01% | Bryant Ranch Prepack | ANDA209913 |
| 72162-1271-6 | 72162-1271 | Fluocinolone Acetonide Topical Solution USP, 0.01% Fluocinolone Acetonide Topical Solution USP, 0.01% | Bryant Ranch Prepack | ANDA209913 |
Drugs@FDA Applications#
| Application | NDC | Name | Marketing category | Labeler |
|---|---|---|---|---|
| ANDA088167 | 0168-0059 | Fluocinolone Acetonide fluocinolone acetonide | ANDA | Fougera Pharmaceuticals, LLC |
| ANDA208386 | 0591-2990 | Fluocinolone Acetonide Topical Fluocinolone Acetonide Topical | ANDA | Actavis Pharma, Inc. |
| ANDA209913 | 21922-003 | Fluocinolone Acetonide Topical Solution USP, 0.01% Fluocinolone Acetonide Topical Solution USP, 0.01% | ANDA | Encube Ethicals, Inc. |
| ANDA206422 | 43386-069 | Fluocinolone Acetonide Fluocinolone Acetonide | ANDA | Lupin Pharmaceuticals,Inc. |
| ANDA089124 | 51672-1365 | Fluocinolone Acetonide fluocinolone acetonide | ANDA | Sun Pharmaceutical Industries, Inc. |
UNII Substances#
No records found.
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.
DailyMed RxNorm Mappings#
| Set ID | RxNorm string | TTY | SPL version | Label | Effective |
|---|---|---|---|---|---|
| ce89966d-d7ea-4986-936e-6d46aee497cd | fluocinolone acetonide 0.01 % Topical Solution | PSN | 104 | Fluocinolone Acetonide Topical Solution USP, 0.01% Rx Only | 20240820 |
| ce89966d-d7ea-4986-936e-6d46aee497cd | fluocinolone acetonide 0.01 % Topical Solution | SY | 104 | Fluocinolone Acetonide Topical Solution USP, 0.01% Rx Only | 20240820 |
| ce89966d-d7ea-4986-936e-6d46aee497cd | fluocinolone acetonide 0.1 MG/ML Topical Solution | SCD | 104 | Fluocinolone Acetonide Topical Solution USP, 0.01% Rx Only | 20240820 |
| 3fa4d5db-b17f-44dc-aa6a-50934d42c68d | fluocinolone acetonide 0.01 % Topical Solution | SY | 102 | Fluocinolone Acetonide Topical Solution USP, 0.01% Rx Only | 20260218 |
| 3fa4d5db-b17f-44dc-aa6a-50934d42c68d | fluocinolone acetonide 0.1 MG/ML Topical Solution | SCD | 102 | Fluocinolone Acetonide Topical Solution USP, 0.01% Rx Only | 20260218 |
| 3fa4d5db-b17f-44dc-aa6a-50934d42c68d | fluocinolone acetonide 0.01 % Topical Solution | PSN | 102 | Fluocinolone Acetonide Topical Solution USP, 0.01% Rx Only | 20260218 |
| 98dfd7a4-2208-4637-acf5-080a5813a433 | fluocinolone acetonide 0.01 % Topical Solution | PSN | 12 | FLUOCINOLONE ACETONIDE TOPICAL SOLUTION, USP 0.01% Rx Only | 20160801 |
| 98dfd7a4-2208-4637-acf5-080a5813a433 | fluocinolone acetonide 0.1 MG/ML Topical Solution | SCD | 12 | FLUOCINOLONE ACETONIDE TOPICAL SOLUTION, USP 0.01% Rx Only | 20160801 |
| 98dfd7a4-2208-4637-acf5-080a5813a433 | fluocinolone acetonide 0.01 % Topical Solution | SY | 12 | FLUOCINOLONE ACETONIDE TOPICAL SOLUTION, USP 0.01% Rx Only | 20160801 |
| 5649e15a-6a7c-4752-ac28-01e453afb37e | fluocinolone acetonide 0.01 % Topical Solution | SY | 10 | FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01% | 20260128 |
| 5649e15a-6a7c-4752-ac28-01e453afb37e | fluocinolone acetonide 0.01 % Topical Solution | PSN | 10 | FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01% | 20260128 |
| 5649e15a-6a7c-4752-ac28-01e453afb37e | fluocinolone acetonide 0.1 MG/ML Topical Solution | SCD | 10 | FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01% | 20260128 |
| 3fb00d90-6a5b-4e95-ab6b-f5b102ff0f36 | fluocinolone acetonide 0.01 % Topical Solution | PSN | 6 | Fluocinolone Acetonide Topical Solution USP, 0.01% Rx Only | 20260318 |
| 3fb00d90-6a5b-4e95-ab6b-f5b102ff0f36 | fluocinolone acetonide 0.1 MG/ML Topical Solution | SCD | 6 | Fluocinolone Acetonide Topical Solution USP, 0.01% Rx Only | 20260318 |
| 3fb00d90-6a5b-4e95-ab6b-f5b102ff0f36 | fluocinolone acetonide 0.01 % Topical Solution | SY | 6 | Fluocinolone Acetonide Topical Solution USP, 0.01% Rx Only | 20260318 |
| 460f5a55-6437-4651-bc08-8063ca579c8d | fluocinolone acetonide 0.1 MG/ML Topical Solution | SCD | 5 | Fluocinolone Acetonide Topical Solution USP, 0.01% Rx Only | 20190221 |
| 460f5a55-6437-4651-bc08-8063ca579c8d | fluocinolone acetonide 0.01 % Topical Solution | SY | 5 | Fluocinolone Acetonide Topical Solution USP, 0.01% Rx Only | 20190221 |
| 460f5a55-6437-4651-bc08-8063ca579c8d | fluocinolone acetonide 0.01 % Topical Solution | PSN | 5 | Fluocinolone Acetonide Topical Solution USP, 0.01% Rx Only | 20190221 |
| b859bc63-a9e3-4a6d-a3f7-711b4eeaba63 | fluocinolone acetonide 0.01 % Topical Solution | PSN | 5 | Fluocinolone Acetonide Topical Solution USP, 0.01% | 20121207 |
| b859bc63-a9e3-4a6d-a3f7-711b4eeaba63 | fluocinolone acetonide 0.1 MG/ML Topical Solution | SCD | 5 | Fluocinolone Acetonide Topical Solution USP, 0.01% | 20121207 |
| b859bc63-a9e3-4a6d-a3f7-711b4eeaba63 | fluocinolone acetonide 0.01 % Topical Solution | SY | 5 | Fluocinolone Acetonide Topical Solution USP, 0.01% | 20121207 |
| 7105ba2c-4159-465e-9f2d-6ebfd13fc8bd | fluocinolone acetonide 0.01 % Topical Solution | PSN | 4 | Fluocinolone Acetonide | 20221103 |
| 7105ba2c-4159-465e-9f2d-6ebfd13fc8bd | fluocinolone acetonide 0.01 % Topical Solution | SY | 4 | Fluocinolone Acetonide | 20221103 |
| 7105ba2c-4159-465e-9f2d-6ebfd13fc8bd | fluocinolone acetonide 0.1 MG/ML Topical Solution | SCD | 4 | Fluocinolone Acetonide | 20221103 |
| 02352ed1-3568-441f-add8-45201351a11c | fluocinolone acetonide 0.01 % Topical Solution | PSN | 3 | Fluocinolone Acetonide Topical Solution USP, 0.01% | 20250703 |
| 02352ed1-3568-441f-add8-45201351a11c | fluocinolone acetonide 0.01 % Topical Solution | SY | 3 | Fluocinolone Acetonide Topical Solution USP, 0.01% | 20250703 |
| 02352ed1-3568-441f-add8-45201351a11c | fluocinolone acetonide 0.1 MG/ML Topical Solution | SCD | 3 | Fluocinolone Acetonide Topical Solution USP, 0.01% | 20250703 |
| 136cb37e-e939-40b5-9725-194b14a9b090 | fluocinolone acetonide 0.01 % Topical Solution | PSN | 2 | NOXIPAK KIT | 20171108 |
| 136cb37e-e939-40b5-9725-194b14a9b090 | fluocinolone acetonide 0.01 % Topical Solution | SY | 2 | NOXIPAK KIT | 20171108 |
| 136cb37e-e939-40b5-9725-194b14a9b090 | fluocinolone acetonide 0.1 MG/ML Topical Solution | SCD | 2 | NOXIPAK KIT | 20171108 |
| f1b8a26a-dc63-4701-8a78-cc1f99fca1b3 | fluocinolone acetonide 0.01 % Topical Solution | SY | 1 | XILAPAK KIT | 20171102 |
| f1b8a26a-dc63-4701-8a78-cc1f99fca1b3 | fluocinolone acetonide 0.1 MG/ML Topical Solution | SCD | 1 | XILAPAK KIT | 20171102 |
| f1b8a26a-dc63-4701-8a78-cc1f99fca1b3 | fluocinolone acetonide 0.01 % Topical Solution | PSN | 1 | XILAPAK KIT | 20171102 |
| 372a6a06-c9de-48d5-ad02-c4004038f85e | fluocinolone acetonide 0.1 MG/ML Topical Solution | SCD | 1 | FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01% | 20091110 |
| 372a6a06-c9de-48d5-ad02-c4004038f85e | fluocinolone acetonide 0.01 % Topical Solution | SY | 1 | FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01% | 20091110 |
| 372a6a06-c9de-48d5-ad02-c4004038f85e | fluocinolone acetonide 0.01 % Topical Solution | PSN | 1 | FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01% | 20091110 |
DailyMed Labels#
| Set ID | Title | Manufacturer | Effective |
|---|---|---|---|
| 3fb00d90-6a5b-4e95-ab6b-f5b102ff0f36 | Fluocinolone Acetonide Topical Solution USP, 0.01% Rx Only | Encube Ethicals, Inc. | Encube Ethicals Private Limited | 20260318 |
| 3fa4d5db-b17f-44dc-aa6a-50934d42c68d | Fluocinolone Acetonide Topical Solution USP, 0.01% Rx Only | Bryant Ranch Prepack | 20260218 |
| 5649e15a-6a7c-4752-ac28-01e453afb37e | FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01% | Fougera Pharmaceuticals, LLC | 20260128 |
| 02352ed1-3568-441f-add8-45201351a11c | Fluocinolone Acetonide Topical Solution USP, 0.01% | Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc. | 20250703 |
| ce89966d-d7ea-4986-936e-6d46aee497cd | Fluocinolone Acetonide Topical Solution USP, 0.01% Rx Only | Bryant Ranch Prepack | 20240820 |
| 270961cf-7ccb-4291-be16-87ce3196b200 | Fluocinolone Acetonide Topical Solution USP, 0.01% | Glasshouse Pharmaceuticals Limited Canada | 20240109 |
| 7105ba2c-4159-465e-9f2d-6ebfd13fc8bd | Fluocinolone Acetonide | Marlex Pharmaceuticals Inc | 20221103 |
| ab896e60-144a-a876-f968-7ff88267d6d8 | Fluocinolone Acetonide Topical Solution, USP 0.01% For Topical Use Only Not For Ophthalmic Use Rx Only | Cosette Pharmaceuticals, Inc. | 20191225 |
| 460f5a55-6437-4651-bc08-8063ca579c8d | Fluocinolone Acetonide Topical Solution USP, 0.01% Rx Only | Lupin Pharmaceuticals,Inc. | Lupin Inc. | Novel Laboratories, Inc. | 20190221 |
| 136cb37e-e939-40b5-9725-194b14a9b090 | NOXIPAK KIT | SOLUTECH PHARMACEUTICALS LLC | 20171108 |
| f1b8a26a-dc63-4701-8a78-cc1f99fca1b3 | XILAPAK KIT | SOLUTECH PHARMACEUTICALS LLC | 20171102 |
| 98dfd7a4-2208-4637-acf5-080a5813a433 | FLUOCINOLONE ACETONIDE TOPICAL SOLUTION, USP 0.01% Rx Only | Actavis Pharma, Inc. | 20160801 |
| e73c8061-3edf-4c0e-93f3-e4144c8853bc | National Council for Prescription Drug Programs | 20130213 | |
| b859bc63-a9e3-4a6d-a3f7-711b4eeaba63 | Fluocinolone Acetonide Topical Solution USP, 0.01% | Teligent Pharma, Inc. | 20121207 |
| c7409cfa-1517-4aba-88cc-19efbc50f41a | National Council for Prescription Drug Programs | 20120724 | |
| 67e9f25f-126d-44e6-ad4f-ef49068f4141 | National Council for Prescription Drug Programs | 20120724 | |
| 372a6a06-c9de-48d5-ad02-c4004038f85e | FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01% | Physicians Total Care, Inc. | 20091110 |
Drug Classes#
| Source | Class ID | Class | Type | Relationship | Drug concept |
|---|---|---|---|---|---|
| ATC | S02BA | Corticosteroids | ATC1-4 | fluocinolone acetonide | |
| ATC | C05AA | Corticosteroids | ATC1-4 | fluocinolone acetonide | |
| ATC | S01BA | Corticosteroids, plain | ATC1-4 | fluocinolone acetonide | |
| ATC | D07AC | Corticosteroids, potent (group III) | ATC1-4 | fluocinolone acetonide | |
| FDASPL | N0000175576 | Corticosteroid | EPC | has_epc | fluocinolone acetonide |
| FDASPL | N0000175450 | Corticosteroid Hormone Receptor Agonists | MOA | has_moa | fluocinolone acetonide |
| MEDRT | D005446 | Fluocinolone Acetonide | CHEM | has_ingredient | fluocinolone |
| MEDRT | D005446 | Fluocinolone Acetonide | CHEM | has_ingredient | fluocinolone acetonide |
| MEDRT | D003876 | Dermatitis, Atopic | DISEASE | may_treat | fluocinolone |
| MEDRT | D003876 | Dermatitis, Atopic | DISEASE | may_treat | fluocinolone acetonide |
| MEDRT | D004342 | Drug Hypersensitivity | DISEASE | ci_with | fluocinolone |
| MEDRT | D004342 | Drug Hypersensitivity | DISEASE | ci_with | fluocinolone acetonide |
| MEDRT | D005148 | Facial Dermatoses | DISEASE | may_treat | fluocinolone |
| MEDRT | D005148 | Facial Dermatoses | DISEASE | may_treat | fluocinolone acetonide |
| MEDRT | D005533 | Foot Dermatoses | DISEASE | may_treat | fluocinolone |
| MEDRT | D005533 | Foot Dermatoses | DISEASE | may_treat | fluocinolone acetonide |
| MEDRT | D006229 | Hand Dermatoses | DISEASE | may_treat | fluocinolone |
| MEDRT | D006229 | Hand Dermatoses | DISEASE | may_treat | fluocinolone acetonide |
| MEDRT | D006967 | Hypersensitivity | DISEASE | ci_with | fluocinolone acetonide |
| MEDRT | D007249 | Inflammation | DISEASE | may_treat | fluocinolone |
| MEDRT | D007249 | Inflammation | DISEASE | may_treat | fluocinolone acetonide |
| MEDRT | D007868 | Leg Dermatoses | DISEASE | may_treat | fluocinolone acetonide |
| MEDRT | D007868 | Leg Dermatoses | DISEASE | may_treat | fluocinolone |
| MEDRT | D011537 | Pruritus | DISEASE | may_treat | fluocinolone |
| MEDRT | D011537 | Pruritus | DISEASE | may_treat | fluocinolone acetonide |
| MEDRT | D011565 | Psoriasis | DISEASE | may_treat | fluocinolone acetonide |
| MEDRT | D011565 | Psoriasis | DISEASE | may_treat | fluocinolone |
| MEDRT | D012536 | Scalp Dermatoses | DISEASE | may_treat | fluocinolone acetonide |
| MEDRT | N0000000159 | Glucocorticoid Receptor Agonists | MOA | has_moa | fluocinolone acetonide |
| MEDRT | N0000000134 | Lipoxygenase Inhibitors | MOA | has_moa | fluocinolone acetonide |
| MEDRT | N0000000134 | Lipoxygenase Inhibitors | MOA | has_moa | fluocinolone |
| MEDRT | N0000008297 | Antipruritic Activity | PE | has_pe | fluocinolone acetonide |
| MEDRT | N0000008663 | Decreased Immunologically Active Molecule Activity | PE | has_pe | fluocinolone acetonide |
| MEDRT | N0000008663 | Decreased Immunologically Active Molecule Activity | PE | has_pe | fluocinolone |
| MEDRT | N0000008841 | Decreased Protein Synthesis | PE | has_pe | fluocinolone |
| MEDRT | N0000008841 | Decreased Protein Synthesis | PE | has_pe | fluocinolone acetonide |
| MEDRT | N0000009908 | Vasoconstriction | PE | has_pe | fluocinolone acetonide |
| MEDRT | N0000009908 | Vasoconstriction | PE | has_pe | fluocinolone |
Properties#
| Category | Property | Value |
|---|---|---|
| ATTRIBUTES | AVAILABLE_STRENGTH | 0.1 MG/ML |
| ATTRIBUTES | GENERAL_CARDINALITY | SINGLE |
| ATTRIBUTES | HUMAN_DRUG | US |
| ATTRIBUTES | PRESCRIBABLE | Y |
| ATTRIBUTES | RXNAV_HUMAN_DRUG | US |
| ATTRIBUTES | SCHEDULE | 0 |
| ATTRIBUTES | TTY | SCD |
| CODES | ANDA | ANDA088167 |
| CODES | ANDA | ANDA089124 |
| CODES | ANDA | ANDA206422 |
| CODES | ANDA | ANDA208386 |
| CODES | ANDA | ANDA209913 |
| CODES | MMSL_CODE | BD3136 |
| CODES | MMSL_CODE | CD3136 |
| CODES | MMSL_CODE | CD7067 |
| CODES | RxCUI | 1191310 |
| CODES | SNOMEDCT | 374493003 |
| CODES | SPL_SET_ID | 02352ed1-3568-441f-add8-45201351a11c |
| CODES | SPL_SET_ID | 3fa4d5db-b17f-44dc-aa6a-50934d42c68d |
| CODES | SPL_SET_ID | 3fb00d90-6a5b-4e95-ab6b-f5b102ff0f36 |
| CODES | SPL_SET_ID | 460f5a55-6437-4651-bc08-8063ca579c8d |
| CODES | SPL_SET_ID | 5649e15a-6a7c-4752-ac28-01e453afb37e |
| CODES | SPL_SET_ID | 98dfd7a4-2208-4637-acf5-080a5813a433 |
| CODES | SPL_SET_ID | ce89966d-d7ea-4986-936e-6d46aee497cd |
| CODES | VUID | 4004176 |
| NAMES | Prescribable Synonym | fluocinolone acetonide 0.01 % Topical Solution |
| NAMES | RXNAV_STR | fluocinolone acetonide 0.1 MG/ML Topical Solution |
| NAMES | RxNorm Name | fluocinolone acetonide 0.1 MG/ML Topical Solution |
| NAMES | RxNorm Synonym | fluocinolone acetonide 0.01 % Topical Solution |
| SOURCES | Source | Gold Standard Alchemy |
| SOURCES | Source | Metathesaurus FDA Structured Product Labels |
| SOURCES | Source | Micromedex RED BOOK |
| SOURCES | Source | Multum MediSource Lexicon |
| SOURCES | Source | National Drug Data File Plus Source Vocabulary |
| SOURCES | Source | US Edition of SNOMED_CT |
| SOURCES | Source | Veterans Health Administration National Drug File |