FDA.reportPublic FDA data

Australian Dream Back Pain

Product NDC
61577-8121
11-digit product format
615778121
Labeler code
61577
Product ID
61577-8121_5256a63e-e6db-84c1-e063-6294a90a8dff
Type
HUMAN OTC DRUG
Nonproprietary name
Histamine Dihydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Sombra Cosmetics Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-09-29
Substance
HISTAMINE DIHYDROCHLORIDE
Active strength
.0005 g/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61577-8121IInactivated by FDA2026-10-27
excluded packagepackage61577-812161577-8121-9IInactivated by FDA2026-10-27

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Australian Dream Back Pain
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HISTAMINE DIHYDROCHLORIDE.0005 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3POA0Q644UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1542820Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5256a63e-e6da-84c1-e063-6294a90a8dffAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61577-8121-9Australian Dream Back Pain266 g in 1 JARCREAM2668
61577-8121-2Australian Dream Back Pain59 g in 1 JARCREAM591
61577-8121-3Australian Dream Back Pain1 in 1 CARTONCREAM11
61577-8121-4Australian Dream Back Pain119 g in 1 JARCREAM1191
61577-8121-5Australian Dream Back Pain1 in 1 CARTONCREAM11
61577-8121-8Australian Dream Back Pain1 in 1 CARTONCREAM11
61577-8121-9Australian Dream Back Pain266 g in 1 JARCREAM2661

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61577-8121AUSTRALIAN DREAM BACK PAIN (HISTAMINE DIHYDROCHLORIDE) CREAM [SOMBRA COSMETICS, INC.]8Current NDC, Legacy NDC, 1 package rows20240119_6555087a-368a-416c-a91e-d3612cb47968.zip

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 57 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AY BENDITO HEMP ROLL-ONCAMPHOR, MENTHOLAY BENDITO INTERNATIONAL, INC3e552afc-9305-8825-e063-6294a90a1afe2025-12-08WarningsExact identifier
application number: M017
AY BENDITO HEMPCAMPHOR, MENTHOLAY BENDITO INTERNATIONAL, INC457d89aa-4a84-94a6-e063-6294a90a20c02025-12-08WarningsExact identifier
application number: M017
Gold Bond Medicated Anti-ItchPRAMOXINE HYDROCHLORIDE, MENTHOLGold Bond Co LLC4a2bd277-47dd-4ae6-9b4b-e0ae9aad226b2025-12-05WarningsExact identifier
application number: M017
Orajel for Cold Sores Double Medicated, CreamBENZOCAINE AND WHITE PETROLATUMChurch & Dwight Co., Inc.b8699a40-8464-ca02-e053-2995a90a42602025-12-05WarningsExact identifier
application number: M017
Thompson Hydrocortisone 1%HYDROCORTISONEThompsonf8740314-7e1f-815e-e053-6294a90a6eae2025-12-05WarningsExact identifier
application number: M017
JUST CBD SOOTHING UNSCENTEDLIDOCAINE HCLJust Brands LLC453f44e2-9e5b-8695-e063-6394a90a43892025-12-05WarningsExact identifier
application number: M017
JUST CBD ROLL-ON COOLINGMENTHOLJust Brands LLC453fa1a7-368c-ae50-e063-6294a90a55072025-12-05WarningsExact identifier
application number: M017
JUST CBD ROLL-ON WARMINGCAMPHORJust Brands LLC4540221f-cf9f-9b6a-e063-6294a90adec32025-12-05WarningsExact identifier
application number: M017
Gold Bond Extra StrengthMENTHOLGold Bond Co LLC3e84375f-95d3-420c-b222-02a7574125922025-12-04WarningsExact identifier
application number: M017
Gold Bond Medicated Pain and Itch ReliefLIDOCAINE HYDROCHLORIDEGold Bond Co LLCd240e9b8-3506-42ab-8a50-05e8d3fac4ff2025-12-04WarningsExact identifier
application number: M017
BLT Skin CreamBENZOCAINE, LIDOCAINE, TETRACAINEM2B Pharma LLC9dc5db9d-9e0a-cd28-e053-2995a90a6bf72025-12-04WarningsExact identifier
application number: M017
AleveXCAMPHOR AND MENTHOLBayer HealthCare LLCbc66bc1b-c0d5-2481-e053-2a95a90a75de2025-12-04WarningsExact identifier
application number: M017
AleveXCAMPHOR AND MENTHOLBayer HealthCare LLCbafd199a-e198-d5d1-e053-2995a90ad1cb2025-12-04WarningsExact identifier
application number: M017
AleveXCAMPHOR AND MENTHOLBayer HealthCare LLCbafdf06b-25f5-e29e-e053-2a95a90a5e1b2025-12-04WarningsExact identifier
application number: M017
Alocane MaxLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products LLC0a35221a-2fcb-2735-e063-6294a90a88ca2025-12-04WarningsExact identifier
application number: M017
Pain RelievingTROLAMINE SALICYLATECARDINAL HEALTH 110, LLC. DBA LEADERb813262e-57c6-4d2c-8cc0-7a17f6f593432025-12-04WarningsExact identifier
application number: M017
Gold Bond Medicated Extra Strength BodyMENTHOLGold Bond Co LLC7b75b7de-9c0b-4edf-b923-320f7d2bb1e62025-12-04WarningsExact identifier
application number: M017
Lidocaine PatchLIDOCAINEShenzhen Finona Information Technology Co., Ltd38767081-7011-6602-e063-6394a90a27842025-12-03WarningsExact identifier
application number: M017
4% Lidocaine Maximum Strength Pain ReliefLIDOCAINEShenzhen Finona Information Technology Co., Ltd3e5a5165-a773-0501-e063-6294a90ae2f42025-12-03WarningsExact identifier
application number: M017
Leader LidocaineLIDOCAINE HCLCARDINAL HEALTHcece6765-0e2f-5ce9-e053-2995a90a37582025-12-03WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1542820histamine dihydrochloride 0.05 % Topical CreamPSN6555087a-368a-416c-a91e-d3612cb479688
1542820histamine dihydrochloride 0.5 MG/ML Topical CreamSCD6555087a-368a-416c-a91e-d3612cb479688
1542820histamine dihydrochloride 0.05 % Topical CreamSY6555087a-368a-416c-a91e-d3612cb479688
1542820histamine dihydrochloride 0.05 % Topical CreamPSN5256a63e-e6da-84c1-e063-6294a90a8dff1
1542820histamine dihydrochloride 0.5 MG/ML Topical CreamSCD5256a63e-e6da-84c1-e063-6294a90a8dff1
1542820histamine dihydrochloride 0.05 % Topical CreamSY5256a63e-e6da-84c1-e063-6294a90a8dff1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61577-8121-26157781210259 g in 1 JAR (61577-8121-2) 59 g2019-12-100000-00-00NoNoCurrent
61577-8121-3615778121031 JAR in 1 CARTON (61577-8121-3) / 59 g in 1 JAR (61577-8121-2) 1 jar2023-09-29NoNoCurrent
61577-8121-461577812104119 g in 1 JAR (61577-8121-4) 119 g2019-12-100000-00-00NoNoCurrent
61577-8121-5615778121051 JAR in 1 CARTON (61577-8121-5) / 119 g in 1 JAR (61577-8121-4) 1 jar2026-02-20NoNoCurrent
61577-8121-8615778121081 JAR in 1 CARTON (61577-8121-8) / 266 g in 1 JAR (61577-8121-9) 1 jar2024-01-18NoNoCurrent
61577-8121-961577812109266 g in 1 JAR266 gHistorical